Apparatus and methods for tendon or ligament repair

ABSTRACT

Apparatus and methods for repairing damaged tendons or ligaments. Various repair apparatus include an elongate tensile member and a pair of anchor structures connected for movement along the tensile member on either side of a repair site, such as a tear or laceration. The anchor structures may take many forms, and may include barbed, helical, and crimp-type anchors. In the preferred embodiments, at least one anchor structure is movable along the elongate tensile member to assist with adjusting a tendon segment to an appropriate repair position and the anchor structure or structures are then lockable onto the elongate tensile member to assist with affixing the tendon at the repair position. The invention further provides tendon-to-bone repair apparatus and methods employing similar concepts. Tendon retrieval devices of the invention include helical members for rotating into a tendon end and subsequently moving the tendon to an appropriate operating position.

[0001] The present application is a continuation-in-part of PCT Ser. No.PCT/US99/24098 filed on Oct. 18, 1999, now pending, which is acontinuation-in-part of U.S. Ser. No. 08/928,866, filed on Sep. 12,1997, now U.S. Pat. No. 6,083,244, which is based on provisional patentapplication Serial No. 60/026,101, filed Sep. 13, 1996, now abandoned,and provisional patent application Serial No. 60/043,086, filed on Apr.8, 1997, now abandoned. The disclosures of each of these prior relatedapplications are hereby fully incorporated by reference herein.

FIELD OF THE INVENTION

[0002] The present invention generally relates to tendon or ligamentrepair apparatus and methods. More specifically, the invention relatesto the repair of severed or otherwise damaged tendons or ligaments andthe attachment of tendons or ligaments to bone. As used herein, theterms “tendon” and “ligament” are used in a generally interchangeablemanner.

BACKGROUND OF THE INVENTION

[0003] The repair of tendons or ligaments is a challenging andcomplication prone area of surgery. As one example, the dilemma inflexor tendon repair surgery in the hand is to adequately connect asevered tendon without compromising the functionality of the hand due tosurgical intervention and repair techniques. Over the past 40 years,there have been only improvements in the basic suture techniques torepair tendons. In order to make any substantial improvement in the artof repairing a severed tendon one must first understand the compositionand structure of tendons and ligaments.

[0004] Tendons can sustain high tensile forces resulting from musclecontraction, yet are flexible enough to bend around bony surfaces anddeflect beneath retinacula to change the final direction of muscle pull.Tendons attach muscle to bone and transmit tensile loads from muscle tobone thereby producing joint movement. Ligaments attach bone to bone andcan flex to allow natural movement of the bones that they attach, butare strong and inextensible so as to offer suitable resistance toapplied forces. Ligaments augment the mechanical stability of thejoints. The biomechanical behavior of tendons and ligaments isviscoelastic or rate dependent, that is, their strength and stiffnessincrease with an increased loading rate. Bundles of collagen fibersembedded in a connecting matrix, known as ground substance, provide theload carrying elements of natural tendons and ligaments. The arrangementof the collagen fibers is nearly parallel in tendons, equipping them towithstand high unidirectional loads.

[0005] The less parallel arrangement of the collagen fibers in ligamentsallows these structures to sustain predominant tensile stresses in onedirection and smaller stresses in other directions. The ground substancein both tendons and ligaments acts generally as a cementing matrixholding the collagen fibers together. The ground substance retains largeamounts of water essential to the non-compressive hydraulic function ofthe moving tissue. Also included in the tendon composition are elasticfibers, tenocytes, small blood vessels and nerves. In general, thecellular material (fibroblasts) occupies about 20% to 38% depending onreferences, of the total tissue volume, while the ground substancematrix accounts for the remaining 62% to 80%. About 70% of the groundsubstance matrix consists of water absorbed in an open polysaccharidematrix.

[0006] Two types of tendons exist in the hand for connecting phalanx(finger) bones to the appropriate muscles. Flexor tendons, which areconnected to the volar or palm side of the fingers, lend the ability tocurl the fingers towards the palm. Extensor tendons, which are connectedto the dorsal or backside of the fingers, return the curled fingers backinto a straight position. Sheaths and retinacula restrain most tendonsin the hand to some extent and keep them close to the skeletal plane sothat they maintain a relatively constant moment arm rather thanbowstringing across the joints. The pulley system of the flexor tendonsheath in the finger is the most highly developed of these restraints.The flexor tendon sheath pulley system permits the flexor tendons tomaintain a relatively constant moment arm and helps minimize stressrisers between tendon and sheath. This system serves three importantfunctions. First, it allows smooth tendon gliding or lubrication;second, the retinacular reinforcing pulleys maintain the flexor tendonsclose to the surface of the finger bones, preventing bowstringing; andthird, it provides an enclosed synovial fluid environment for tendonnutrition and lubrication. As the finger moves, each tendon slides acertain distance, which defines the “excursion of the tendon”. Excursiontakes place simultaneously in the flexor and extensor tendons duringjoint motion. The tendons of the agonist, or contracting muscle,displace in one direction. The tendons of the antagonist or resistingmuscles displace in the opposite direction to accommodate the motion.

[0007] Today, the most common methods of repairing torn, severed orotherwise damaged tendons involve approximating the severed ends of thetendons and suturing one side of the tendon to the other therebyreturning the tendon to its natural position. A popular suture techniqueis the so-called Kessler technique and slight modifications thereof.Some of the other techniques include the Becker, Savage, lateral trap,double loop locking suture, four-strand interlock and variations of theHalsted technique. Other methods place prosthetic material either withinor around the tendon. Polyester strips and sleeves along with polyestermesh have been used to reinforce the suture/tendon interface to providea stronger repair.

[0008] After flexor tendon repair, resistance to tendon glidingincreases at the repair site. Repair techniques that use an increasednumber of suture strands, or increased amounts of suture material orprosthetic material promote greater glide resistance. In particular,adhesions form due to the tendon's natural response to healing, i.e.,the ingrowth of cells and vessels from surrounding connective tissue.Current literature suggests adhesions may constitute an inflammatoryprocess at the site of repair and an extension of the intrinsic tendonhealing process to the surrounding tissue.

[0009] An ideal repair would exhibit high strength, flexibility, and ajoining of the tendon ends without any foreign material on the outsidesurface of the tendon. Physical therapy should begin immediately afterthe repair to prevent the tendon from adhering to the tendon sheathcreating adhesions that limit the full excursion of the tendon in itssheath. For this reason, the repair site must withstand the immediatetensile stress being applied to it during physical therapy. In a relaxedstate, a flexor tendon experiences about one pound of constant tension.When a person applies a light grip, such as by grasping a key, aboutthree to four pounds of tensile force is applied to the tendon. A stronggrip can apply over ten pounds of tensile force to a tendon.

[0010] Since most suture-based tendon repairs reach their tensile limitat about 6 lbs., surgeons must balance the desire to have full andimmediate active motion to prevent adhesions against the need forimmobilization to prevent rupture of the repair. Earlier loading of arepaired tendon promotes a more rapid increase in repair strength. For atendon to properly rejoin, the opposed tendon ends do not have to touchbut they do need to be approximated within 1-2 mm of each other toproperly reattach. An ideal tendon repair would hold the laceratedtendons together to begin healing and tissue generation but slowlyrelease tension allowing the tendon to become the primary load bearingstructure. Tendons will heal at a rate that is proportional to the loadbeing applied during physical therapy.

[0011] Another major problem is the softening of the damaged tendonends, which begins shortly after the damage or injury occurs andcontinues for approximately the next twelve days. This softening resultsin a weakening of the tendon fibers, which contributes to the formationof a gap at the repair site during the early phases of tendon healing.It is believed that gaps form at the site of repair due to a loss ofpurchase by the grasping portion of the suture at the tendon-sutureinterface. The grasping suture may even completely tear out, resultingin a failure of repair. A term for this failure is “rake-out”. Rake-outis a failure mode associated with suture tendon repair in which the endof the severed tendon has weakened and the suture tends to pull out ofthe tendon ends. This splits the tendon and results in an undesirablegap or total failure. Another common type of suture repair failure is ofa suture knot.

[0012] The effectiveness of a suture depends on many factors, such asthe suture material, the technique with which the suture is inserted,and knot strength. Immediately after a tendon is repaired, the strengthof the repair depends almost entirely on the suture technique. The idealsuture knot should terminate securely, be strong, easy to handle andinelastic. The suture material used today is generally braided polyesteror a monofilament polypropylene. Using current suture techniques,absorbable suture materials do not have enough residual tensile strengthover time to resist gapping and rupturing. The ideal suture techniqueshould be easy to use, minimize interference with tendon vascularity andbe completely internal to the tendon without increasing the bulk of thetendon. Locating the knots outside the tendon rather than within therepair site may result in higher ultimate tensile strength but will alsoincrease the risk of adhesions and increase the friction through thepulleys. This latter characteristic is known as “work of flexion”.

[0013] Most suture methods employ an internal suture with external knotsdistal and proximal to the laceration or within the laceration. Thesurgeon typically uses a continuous running external suture at thejunction of the repair, known as an epitendinous suture, to approximatethe tendon ends. The use of the epitendinous suture increases thetensile strength of the repair and helps to resist gapping, but it canalso increase the risk of adhesions and is difficult to master and verytedious to execute. The evolution of tendon repair with sutures startswith the two-strand technique. Some of the variations of this techniqueare the Bunnell, Kessler, and Tsuge methods. When two-strand repairsfail, the failure usually occurs at the knots. Studies have shown thatthe initial strength of these repairs is proportional to the number ofsuture strands that cross the repair site. This has led to a trend ofdoubling, tripling, and even quadrupling the number of strands placedacross the repair site. With these multiple strand techniques, Savage,Becker and Ketchum have shown significant tensile strength over thetwo-strand methods but they are more difficult to perform and addmaterial to the outside surface of the tendon with more exposed knots.These techniques focus primarily on the increased effect on tensilestrength and disregard the increased resistance to the tendon glidingthrough the pulleys. Therefore, the quest continues for the ideal suturetechnique having the tensile strength required to allow the patient tostart physical therapy immediately, and having the low profile necessaryto minimize adhesions that compromise the ability of the tendon to glidethrough the pulleys.

[0014] Techniques have also been developed that incorporate an internalor external prosthetic splint. Low porosity woven polyester, which isthe same material used for aortic graft repair, is being used as anartificial splint. There are basically two methods of splint repair. Theinternal splint technique is accomplished by placing a horizontal slittransversely in each tendon stump proximal and distal to the lacerationsite. A rectangular piece of polyester splint is placed into this sliton both sides of the tendon. Sutures are then placed perpendicular tothe graft along each tendon thereby attaching the splint to the tendon.The sutures attach the splint, which is basically a flexible tensilemember, to the interior surface of the tendon. These suture knots arethen tied on the outside of the tendon for ease of placement and anepitendinous suture is placed at the junction of the repair. Aspreviously mentioned, the external knots will increase the risk foradhesions and also increase the work of flexion. The material of thetendon splint is inert and similar to the suture material being used inother techniques and its internal position within the substance of thetendon should promote tissue ingrowth and enhance the repair site.However, the large slits in the tendon ends might structurally damagethe internal blood supply of the tendon and cause tissue degeneration.

[0015] In the external splint technique, also known as the dorsal tendonsplint technique, the surgeon aligns both tendon ends and places atwo-strand Savage type core suture on the anterior surface of thetendon. The surgeon then places a rectangular Dacron® splint on thedorsal surface of the tendon across the laceration site and sutures itto both tendon ends. In this technique, and as mentioned earlier, thesplint acts as a flexible tensile member that prevents the tendons fromgapping and rupturing during early movement. As with the internalmethod, the knots are placed on the exterior surface of the tendons andthe splint is actually on the outside surface. This will increase therisk of adhesions and consequently increase the work of flexion. Theinternal tendon splint may add too much bulk to the repair site, and theexternal tendon splint may interfere with tendon gliding. Preliminarywork of flexion studies suggest both tendon splints increase the work offlexion by 16-19%.

[0016] Another splint-type technique being used today is a Dacron® orProlene® mesh sleeve that surrounds the tendons. The two ends of thelacerated tendons are placed in the proximal and distal openings of thesleeve. The tendon ends are butted together without any additionalsutures, except that an epitendinous suture is placed thereby attachingthe sleeve to the outside surfaces of the tendons. This is done on bothends of the sleeve. This technique is 117% stronger in tension than aconventional two-strand core stitch technique with an epitendinoussuture on the external surface. Like the aforementioned splinttechniques, these are tested in vitro (outside of the body) and do nottake into account any of the in vivo (inside the body) problems thatoccur such as placing a significant amount of repair material externalto the tendon and within the tendon sheath. Again, external repairmaterial provides a potential source of fibrous adhesions and anincrease in work of flexion.

[0017] Implanted anchors have also been used to attach two ends of asevered tendon. This type of anchor is similar to a Dacron® splint inconcept but is usually fabricated from stainless steel or titanium. Thegeometry of the anchor also differentiates the anchor from a splint. Theanchor, which may measure 20 mm in length, 3 mm in width and 1 mm inthickness, has a symmetrical double barbed end configuration. The anchoris placed into the severed end of the tendon by making a smalltransverse incision. Once the anchor is in the correct depth the surgeonwill place a suture through the tendon at the flat side of the barb andknot the suture into a loop thereby preventing the barb from beingpulled out of the tendon. The tendon will be sutured at each flat on thebarb, providing two suture loops per tendon end. The same suturetechnique is performed on both ends thereby re-attaching the severedtendon. This repair technique shows an increase in mean ultimate tensilestrength of 49-240% over traditional two-strand and multi-strand suturetechniques. This technique is relatively easy to perform but it does notaddress the in vivo problems caused by placing the suture knots on theoutside of the tendon. Here, they become a potential source of fibrousadhesions and increase the work of flexion. This type of tendon anchorcan limit motion or cause pain when positioned directly over a jointwith the finger in maximal flexion since it is long and fairly rigid.Also, the surgeon must still bring the tendon ends together with aseparate surgical tool and, in the process, risk damaging the tendonends. Adhesives have been evaluated in the search for the ideal tendonrepair. Studies have been conducted using adhesives of the cyanoacrylategroup, more commonly known as super glues. These adhesives form a strongadhesive bond with most human tissue, particularly those containing alarge amount of protein, such as skin and tendon tissue, because theypolymerize in the presence of water and hydroxyl groups, both of whichare abundantly present in tendon tissue, and they do not require asolvent. They are known to be biodegradable, although the time taken todegrade in tendons is unknown and only the long chain varieties areknown to be minimally toxic to human tissue. The application ofadhesives in tendon repair is in conjunction with two-strand ormulti-strand core suture with an epitendinous suture. The adhesive isplaced on the tendon ends after the sutures have been placed andapproximated to allow for polymerization. The shortcomings that werediscussed in connection with suture repair are experienced with adhesivetechniques as well. Some problems with adhesives include their potentialnon-biodegradability within the tendon, their questionable effect ontendon healing, and their potential local and systemic toxicity.Currently, therefore, adhesives do not provide an adequate solution totendon repair problems.

[0018] Current and past tendon or ligament repair techniques concentrateon increasing the tensile strength of the repair by adding morestructural components to the repair, e.g., sleeves, splints, additionalsuture strands, additional knots and adhesive. All of these techniquestrade off between early tensile strength, increased work of flexion, andincreased risk of adhesions or other problems. While the surgeon debatesthe clinical technique, the patient may suffer from a less thandesirable outcome and discomfort over the life of the repair. Adhesionscause pain and limit motion of the affected joints. By increasing bulkto the tendon, motion may be further limited and this can result in adefect called “trigger finger.”

[0019] None of these techniques have utilized the physiological makeupof the tendon to provide a stronger repair. The tensile strength of thetendon is provided by the lengthwise parallel collagen fibers, whichgive it the ability to withstand high tensile loads. The groundsubstance is made up primarily of water and cannot be used to providestrength to the repair. The tendon sheath is also too weak to providemeaningful assistance with holding the two tendon ends together.

[0020] Similar problems arise when attaching tendons or ligaments tobone. That is, simply suturing the tendon or ligament to a bone anchoror using external tendon anchor members may not provide the necessarystrength of repair. As further discussed above, these techniques alsopromote adhesion formation.

[0021] Finally, tendon retrieval has also been a problematic portion oftendon repair surgery. Typically, the surgeon must use a small graspingtool with thin, movable jaws similar to needle-nose pliers to grasp atendon end and pull and transfix it in an appropriate operatingposition.

[0022] Unfortunately, gripping the tendon ends in this manner oftendamages them and makes the tissue less able to hold the epitendinoussuture. The damaged tendon ends will also form scar tissue or adhesionswhich further adversely affect the repair.

[0023] Therefore, there is a need for tendon repair techniques andapparatus that harness the intrinsic strength of the tendon fibers, butallow the tendon to flex while moving through the sheath. This repairapparatus should resist any gapping or rupture during immediatepost-operative physical therapy, and reside in the interior of thetendon to reduce or possibly eliminate post-operative adhesions. Therepair apparatus should also produce low work of flexion while glidingunhindered through the tendon sheaths. There is generally a need fortendon repair apparatus and methods that allow the patient toimmediately begin active physical therapy without risking any tendonrepair failure while minimizing or eliminating the need for sutures orother repair structure on the external surfaces of the tendon therebyreducing the occurrence of adhesions and friction between the tendonrepair and the sheath pulley. There is a further need for tendon-to-bonerepair techniques and apparatus with at least some of these attributes.Finally, there is a need for a tendon retrieval device which alsoharnesses the inherent strength of the tendon fibers and minimizesdamage to the retrieved tendon end.

SUMMARY OF THE INVENTION

[0024] The present invention generally provides apparatus for repairingdamaged tendons or ligaments. The various repair apparatus according tothe invention employ an elongate tensile member adapted to extend withinthe interior of the tendon or ligament and various types of anchorstructures configured for insertion within the interior of the tendon orligament. The anchor structures are both movable along and lockable tothe elongate tensile member at a selected position. As some examples,these anchor structures may comprise helical anchors with separatelyconnectable tendon fiber retaining members, unitary helicalanchor/tendon fiber retaining member assemblies, compressible helicalanchors, anchor bodies secured inside the tendon with sutures orprojections such as barbs, and crimp-type anchor members that griptendon fibers between two crimp portions or members, as well as otherconfigurations. Various embodiments of repair apparatus are disclosedherein each serving to address the general needs and drawbacks presentedby the prior art as discussed above.

[0025] Among the various advantages and objectives of this invention,apparatus comprising at least one tendon or ligament anchor structure incombination with an elongate tensile member are provided and utilize theinherent strength of the bundles of parallel collagen fibers in tendonsor ligaments. Repair techniques are provided that address the tensilecomponent of the repair and eliminate the increase of bulk to the tendonor ligament. This is accomplished while reducing externally placedcomponents that compromise the ability of the tendon to glide throughthe pulleys. Through an understanding and utilization of the inherentstrength provided by the bundles of parallel collagen fibers, theinventors have developed anchor structures that grasp these highstrength fibers without constricting the blood flow to the tendon, andwithout adding external bulk or additional knots. The anchor systems ofthis invention further allow the patient to begin immediate activemotion physical therapy resulting in a quicker and stronger tendonrepair with fewer adhesions. Also, the combined anchor structure andelongate tensile member of this invention provide a tendon or ligamentrepair that can withstand greater tensile loads than current and pastrepair techniques while retaining the repaired tendon or ligament endsin a viable repair position.

[0026] Generally stated, the present invention comprises at least oneanchor structure coupled for movement along the length of an elongatetensile member. The anchor structure is lockable at a desired locationalong the tensile member and generally includes first and second fibergripping portions configured for insertion within the interior of atendon or ligament. The gripping portions may be on two separatecomponents of the anchor structure or may be portions of the samecomponent. In several embodiments of the invention, at least one of thefiber gripping portions is movable with respect to the other to grip thefibers therebetween. Many different configurations of anchor structuresare disclosed herein including single-piece anchor structures andmulti-piece anchor structures. In the single-piece anchor structures,one portion of a member, such as a crimp member, is movable towardanother portion of the member to grip tendon fibers therebetween. Inother embodiments, separate pieces of the anchor structure are broughttogether and locked to grip, engage or compress the tendon fiberstherebetween. In the most preferred embodiments, two anchor structuresare each initially movable along the length of the elongate tensilemember on opposite sides of a torn, lacerated or otherwise damagedportion of the tendon. The anchor structures may be locked to the fiberswithin the tendon and to the elongate tensile member itself when thetendon is at the proper repair position. Various more specificembodiments of the anchor structures and elongate tensile members ofthis invention are described hereinbelow.

[0027] In one embodiment of the invention, an anchor body in the form ofat least one helical anchor is configured for insertion within theinterior of the tendon or ligament. At least one retaining member iscoupled with the elongate tensile member and provides a securingstructure to hold the helical anchor to the fibers extending within theinterior of the tendon or ligament. In a preferred apparatus of thistype, first and second helical anchors are provided with respectivefirst and second retaining members each being couplable for movementalong the elongate tensile member on opposite sides of a repair site.The retaining members may each include, for example, an axial hole toallow this movement. Optionally, a lengthwise slot may be provided inthe retaining member. In this embodiment, and the other embodiments ofthe invention, the elongate tensile member may comprise a rigid,semi-rigid or flexible member, including flexible sutures formed fromabsorbable or non-absorbable materials, as well as tensile membersformed from various biocompatible metals, plastics, ceramics, etc. Thehelical anchor preferably comprises a helically wound coil which may beof constant or variable diameter and may be formed of biocompatiblemetal. Optionally, the coil may be formed from absorbable material orother non-absorbable biocompatible materials. The retaining member ispreferably configured to be received within a corresponding helicalanchor for compressing the fibers between the retaining member and thehelical anchor. When the helical anchor is rotated into the tendon orligament, fibers of the tendon or ligament will be captured within thecoils of the anchor. When the retaining member is then inserted andaffixed within the helical anchor, the outer surface of the retainingmember compresses the fibers against inner surfaces of the helicalcoils. Preferably, locking structure in the form of at least one lockingmember is used for holding the retaining member to the elongate tensilemember at a desired position. This locking member may be a separateslidably adjustable member or an integral portion of the correspondingretaining member and may, for example, comprise a deformable orcrimpable portion of the retaining member or a separate crimp member.

[0028] The retaining member or members preferably have associatedretaining structure either integrated therein or used as separatestructure for gripping the tendon fibers against the helical anchor. Forexample, the retaining structure may comprise a discontinuous surfaceadapted to aid in holding the fibers between the retaining member andthe helical anchor. As examples, this discontinuous surface may be anexterior serrated surface, a generally threaded surface, or another typeof convoluted or discontinuous surface. This surface may also serve toprevent the retaining member from backing out of the helical anchor.

[0029] As another feature, the elongate tensile member and therespective retaining member or members may include respective engageableportions, such as ratchet-like portions, for holding the retainingmember at the desired position along the elongate tensile member.

[0030] As still another feature, at least one of the elongate tensilemember, the first helical anchor and the retaining member may becomprised of an absorbable material. During the absorption process, thiswill allow a gradual transfer of tensile load to the repair site to aidin healing. More generally stated, at least one component of the anchorsystem will be made from an absorbable material, such as polyglycolicacid or polyglyconate. This will allow for the tensile stress of theanchor system to be gradually transferred from the anchor system to thetendon during the healing of the tendon repair site. As revealedpreviously, the healing response of the tendon is directly proportionalto the amount of tension being applied to the tendon. In other words,more tension on the tendon results in a stronger repair. However, theinitial condition of the repaired tendon does not withstand any tensileload. Therefore, a timed release of the tension being applied to thetendon will result in a stronger repair. By making a key component orcomponents from an absorbable material, the repair apparatus slowlytransfers tension to the tendon until the component(s) completelydegrade and releases all the tension to the tendon repair site.

[0031] As an additional feature of the invention, the retaining membersmay include structure configured to directly engage the helical anchorto prevent the retaining members from backing out of the helical anchorsafter implantation. As one example, this may include ratchet-typestructure on the retaining member adapted to engage the trailing end ofthe helical anchor.

[0032] The retaining members of the various embodiments of thisinvention may also have various configurations. One configuration is ahelical retaining member. In this case, the helical anchor will beeither received within the helical retaining member or may receive thehelical retaining member. Either construction forms inner and outerhelical members. This is helpful because the helical members willcompress tendon or ligament fibers therebetween in a generallysinusoidal pattern. At least one of the inner and outer helical membersis collapsed or expanded toward the other to clamp or compress thetendon or ligament fibers therebetween. This may be accomplished, forexample, through mechanical spring action of the helical members duringinsertion or through the use of electromagnetic impulse deformation. Inthe latter case, and as detailed further below, one helical member maybe formed of a magnetic material while the other is not. Upon theapplication of one or more impulses of electromagnetic energy, themagnetic helical member will collapse onto the nonmagnetic helicalmember compressing the tendon fibers therebetween.

[0033] As another option, the helical anchor of this invention may beformed from a flexible suture material. In this case, the retainingmember is adapted to be inserted into the tendon or ligament and theflexible suture material is then wrapped generally helically about theretaining member to hold the tendon or ligament fibers therebetween. Asthe flexible suture material which is wrapped around the retainingmember is not held in significant tension, it may be formed of materialhaving lower tensile strength than the elongate tensile member.

[0034] In another embodiment of the invention, the apparatus maycomprise first and second helical anchors integrally formed from a wirewith the elongate tensile member extending therebetween. In thisembodiment, the anchors are helically wound in opposite directions suchthat rotation of the integral apparatus in a single direction, with theelongate tensile member disposed generally between the damaged orsevered tendon ends, will cause rotation of each respective helicalmember into a respective tendon end. Retaining members in accordancewith the invention may then be used to grip, compress or otherwiseengage the tendon fibers to the helical anchors.

[0035] In yet another embodiment of the invention, the apparatus mayinclude a helically coiled, compressible anchor configured for insertionwithin the interior of the tendon or ligament and couplable with theelongate tensile member. This compressible anchor traps the fibers ofthe tendon or ligament between the coils as its coils are moved fromtheir uncompressed state to their compressed state. As with the otherembodiments of this invention, the apparatus preferably includes asecond anchor structure in the form of another helically coiled,compressible anchor which is also couplable to the elongate tensilemember. It should also be noted that the elongate tensile member of thisinvention may be formed by two or more separate tensile members, such assutures, which are then tied or otherwise directly or indirectly affixedtogether during the repair procedure such that a unitary elongatetensile member is formed connecting at least two anchors together tohold the tendon or ligament in an approximated repair position. In otherwords, the elongate tensile member may be formed from a number ofdifferent segments or portions which are ultimately secured together andsecured to the anchor structures. In the embodiment employingcompressible anchors, these anchors are also preferably coupled formovement along the elongate tensile member and include respectivelocking members, preferably slidably coupled to the elongate tensilemember, and adapted to hold the compressible anchors at desiredlocations on the elongate tensile member. The locking members may be,for example, formed as crimp members or other structures formedintegrally or separately from the corresponding compressible anchor.

[0036] The retaining members of this invention may also be slottedmembers. In a general sense, this allows the retaining member to becoupled to the elongate tensile member without necessarily using asliding motion along the tensile member as with a retaining member thatincludes an axial hole. The slot or slots may further act as a colletstructure configured to clamp onto the elongate tensile member uponinsertion into the helical anchor or through the use of a separate tool.In another advantageous embodiment of a collet structure, the retainingmember may be a two-piece slotted collet structure with an interiorpiece and an exterior piece. Upon insertion of the exterior piece intothe helical anchor and the interior piece into the exterior piece, theinterior piece is configured to clamp onto the elongate tensile memberand the exterior piece is configured to expand within the helical anchorto compress the fibers against the helical anchor.

[0037] In yet another embodiment, the elongate tensile member will belocked to the helical anchor by trapping the elongate tensile memberbetween the internal retaining member and the helical anchor. This willeliminate the need to have a locking feature built into the internalretaining member in order to lock the elongate tensile member to thehelical anchor.

[0038] In yet another embodiment, the tendon repair apparatus hasmultiple helical anchors. In this embodiment, there is more than onehelical anchor placed within the tendon. The helical anchors may bewound in opposite directions and/or intertwined together. Thisconfiguration is based on the aforementioned method of grasping parallelcollagen fibers. An advantage to multiple anchors is that the amount ofcollagen fibers being trapped is directly proportional to the amount ofcoils on the helical anchor. Increasing the length and the number ofcoils of the helical anchor likewise increases the amount of trappedcollagen fiber. Since there are limitations to the length of the anchor,an additional anchor of the same length is placed in the tendon.

[0039] Another more specific anchor structure of this invention utilizesa crimp-type anchor member. In this embodiment, one of the fibergripping portions further comprises at least one first deformableportion adapted to be crimped within the tendon or ligament to grip thefibers. In one specific embodiment, the crimp member will have opposedlegs that may be deformed toward one another and onto the tendon fibers.The crimp member may further include a second deformable portionconfigured to be crimped onto the elongate tensile member to retain thecrimp member at a desired location thereon. In a related embodiment, theanchor structure may further comprise first and second separate crimpmembers adapted to be crimped onto the fibers generally from oppositesides of the elongate tensile member. The first and second crimp memberscan each include a respective plurality of deformable legs configured tointerlock after crimping to securely hold the first and second crimpmembers to the tendon fibers. The first and second crimp members canfurther include respective crimp portions configured to be crimped ontothe elongate tensile member to retain the first and second crimp membersat a desired location along the length of the tensile member. As oneother alternative, a separate locking member may be used to retain thefirst and second crimp members at a desired position along the length ofthe elongate tensile member.

[0040] In another aspect, the anchor structures further comprise firstand second anchor bodies with respective first and second securingstructures. These securing structures may, for example, compriseprojections extending respectively from the first and second anchorbodies that retain the anchor bodies within the tendon or ligament. Theanchor bodies may be tubular-shaped members or members having variousother shapes configured for insertion within the tendon or ligament. Asanother alternative or additional securing structure, the anchor bodiesmay include portions for receiving sutures used to secure the first andsecond anchor bodies within the interior of the tendon or ligament. Aswith the previous embodiments, the locking structure can, for example,include a crimpable or swageable member or an integral portion of ananchor body operable to affix the anchor body onto the elongate tensilemember. In many of the embodiments of this invention, two anchor bodiesare each initially connected for movement along the elongate tensilemember and first and second respective locking structures or members areused to lock each anchor body to the elongate tensile member with thetendon or ligament in a desired repair position.

[0041] As a further aspect, the invention provides apparatus foraffixing a tendon or ligament to a bone. In this embodiment, theapparatus includes an elongate tensile member, a tendon or ligamentanchor structure constructed in accordance with any of the anchorstructures of this invention, and a bone anchor. The elongate tensilemember, for example, may be a flexible suture adapted to extend withinthe interior of the tendon or ligament. The bone anchor is coupled withthe elongate tensile member and is configured to be retained within thebone. As a more specific feature of the preferred embodiment of thisinvention, the tendon or ligament anchor may be a helical anchor asgenerally described above and may be compressible. A retaining member isadapted to be retained at a selected position along the elongate tensilemember to hold the bone anchor, elongate tensile member and helicalanchor together with the tendon or ligament against the bone. Theretaining member and the bone anchor may include cooperating lockingportions for connecting the retaining member and bone anchor togetherwith the helical anchor held generally therebetween. Alternatively, orin addition, the retaining member may be sized and configured to bereceived at least partially within the helical anchor and a lockingmember, such as a crimp, may be coupled with the elongate tensile memberto hold the retaining member at a desired position. As with the otherembodiments of this invention, the locking member may be, for example, adeformable and slidable crimp member either separately formed orintegrally formed with the retaining member.

[0042] In another aspect of the present invention, a tendon or ligamentretrieval device is provided and operates to move a tendon or ligamentend to a desired operating position. The device generally comprises anelongate body, a helical member coupled with the elongate body and atleast one drive mechanism coupled with the helical member for effectingrotational movement of the helical member into the tendon or ligamentand subsequent translational movement of the helical member to move thetendon or ligament to the desired operating position. To facilitate thisfunction, the helical member is mounted for rotational and translationalmovement relative to the elongate body. The elongate body is adapted tobe inserted into a tendon sheath, for example, and is preferablyflexible to allow manipulation therein by the surgeon. The elongate bodymay also include a distal tip with anti-rotation structure for engagingthe tendon or ligament end and preventing rotation thereof as thehelical member rotates into the tendon or ligament end. As one optionalanti-rotation feature, the helical member may further include first andsecond, counter-rotating helical grasping bodies each being connectedfor rotation and translation by the drive mechanism.

[0043] Various methods are also contemplated in accordance with theinvention relative to tendon or ligament repair. A representative methodinvolves installing an elongate tensile member within the tendon orligament and driving a first helical member into the tendon or ligament.The first helical anchor is secured to the elongate tensile member and asecond helical anchor is driven into the tendon or ligament. The tendonor ligament is then moved to a repair position at least prior tosecuring the second helical anchor to the elongate tensile memberwhereupon the second helical anchor is then securely fastened to theelongate tensile member to hold the tendon or ligament in the repairposition. The various tendon or ligament anchor structures disclosedherein may be used for carrying out the repair methods and additionalrepair methods will become more apparent upon review of the detaileddescription of this invention.

[0044] In another embodiment of the invention, a helical anchor iscoupled to a tendon fiber retaining member to form a unitary anchorassembly. The anchor and attached retaining member are driven into thetendon or ligament at one time. This aspect of the invention furtherincludes an insertion tool for driving the assembly into the tendon orligament preferably with a simultaneous rotating and translatingmovement. More specifically, the anchor assembly comprises a coreportion or retaining member positioned inside of a helical anchor withthe distal end of the anchor preferably being tapered or sharpened toease insertion and also extending distally outward of a distal end ofthe retaining member. The distal end of the retaining member may also betapered and the outer surface can include a helical groove or generallyhelically configured surface which generally corresponds with thehelical anchor. At the proximal end of the retaining member, a slot isprovided and the proximal end of the anchor resides in the slot and issecured in a suitable manner, such as through laser or resistencewelding. The extreme proximal end of the core portion or retainingmember includes tool engagement structure, such as a slot, which allowsthe insertion tool to be used to rotate and translate the assembly intothe tendon or ligament. The core portion or retaining member includes acentral bore through which the elongate tensile member extends and, inthe preferred manner of making and using this embodiment, a separatecrimp member is secured to the tensile member at the proximal end of thecore portion or retaining member. However, integral crimp members orother types of locking members may be used instead. The separate crimpmember of this embodiment has an annular groove in its outer surface toreduce the force necessary to collapse the crimp on the elongate tensilemember.

[0045] A unique crimp tool is provided with a jaw configuration whichboth collapses the crimp, when desired, and which retains the crimpbetween the jaws prior to use, such as during packaging, shipping, andstorage. For this latter purpose as well, a flexible or frangible bar iscoupled between two handles of the crimp tool and aids in holding thejaws in a closed position to retain the crimp therein prior to use, butalso prevent the jaws from moving together and prematurely collapsingthe crimp until necessary during surgery. The bar or bars may be formedof a suitable material, such as plastic, which will bend or fractureduring use. The jaws also include a projection on one jaw and a recessin an opposing jaw for receiving the crimp member. During use, theprojection is forced against the crimp member to collapse the crimpmember against the tensile member. The recess includes a ridge forregistering in the annular groove of the crimp member and therebyassisting to hold the crimp member therein.

[0046] The method of using the unitary anchor assembly generallycorresponds to the broader aspects of the methods disclosed herein. In amore specific and preferred method of using the embodiment of thisinvention which comprises a unitary helical anchor and tendon fiberretaining member, an anchor assembly is driven into the tendon orligament on each side of the damaged or lacerated area. An elongatetensile member having a needle at one end and a preset crimp member atan opposite end is then threaded through the proximal end of a first oneof the anchor assemblies and into the space between the ends of thedamaged tendon or ligament. A second capturing member, such as avena-puncture or syringe needle is then inserted through the proximalend of the second anchor assembly and into the space between the damagedor lacerated tendon or ligament ends. The needle coupled to the elongatetensile member is then captured, such as by inserting its end into thesyringe needle, and the elongate tensile member is pulled through thesecond anchor assembly. A crimp member is then threaded onto theelongate tensile member to a position abutting the proximal end of thesecond anchor assembly and the tendon or ligament ends are pulledtogether to the desired position. The crimp member is then deformed orcollapsed onto the tensile member to fix the tensile member and twoanchor assemblies at the desired length. The excess length of thetensile member is then cut at the proximal end of the second anchorassembly and any necessary additional closing procedures are performedby the surgeon.

[0047] As one additional aspect of the invention, a removal tool isprovided which is especially useful for the latter embodiment andcomprises a rotatable tool having a pointed needle projecting from atool driver head. The tool driver head is configured to engage the toolengagement structure on the proximal end of the unitary anchor assemblyand, in the preferred embodiment, comprises a generallyconventionally-shaped screwdriver projection complementary to a slot inthe proximal end of the anchor assembly. It will be understood that manytypes of tool engagement structure may be used for this purpose.

[0048] Various additional features, advantages and objectives of theinvention will become more readily apparent to those of ordinary skillin the art upon review of the following detailed description of thepreferred embodiments, taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0049]FIG. 1 is a perspective sectional view of the bone repair deviceaccording to the present invention;

[0050]FIG. 2 is a side view of the suture to be used with the bonerepair device according to the present invention;

[0051]FIG. 3 is a sectional view of the suture in place in a bone to berepaired in accordance with the present invention;

[0052]FIG. 4 is a sectional view of a fractured bone repaired with thebone repair device according to the present invention;

[0053]FIG. 5 is a sectional view of a first embodiment of a button to beused with the bone repair device of the present invention;

[0054]FIG. 6 is a sectional view of a second embodiment of a button tobe used with the bone repair device of the present invention;

[0055]FIG. 7 is a top view of a third embodiment of a button to be usedwith the bone repair device of the present invention;

[0056]FIG. 8 is a side view of a third embodiment of a button to be usedwith the bone repair device of the present invention;

[0057]FIG. 9 is a sectional view of the third embodiment of a button tobe used with the bone repair device of the present invention beingattached to a suture;

[0058]FIG. 10 is a sectional view of a fourth embodiment of a button tobe used with the bone repair device of the present invention beingattached to a suture;

[0059]FIG. 11 is a perspective view of the bone repair device of thepresent invention being used to repair a torn or fractured meniscus;

[0060]FIG. 12 is a top view of the incisions made in a hand in the priorart to repair a torn tendon;

[0061]FIG. 13 is a top view of the incisions made in accordance with thepresent invention to repair a torn tendon;

[0062]FIG. 14 is a sectional view of a tendon being repaired inaccordance with the present invention;

[0063]FIG. 15 is a sectional view of a tendon being repaired using afirst embodiment of a button;

[0064]FIG. 15A is a cross-sectional view of a first embodiment of abutton as shown in FIG. 15;

[0065]FIG. 15B is a cross-sectional view of a second embodiment of abutton as shown in FIG. 15;

[0066]FIG. 15C is a cross-sectional view of a third embodiment of abutton as shown in FIG. 15;

[0067]FIG. 15D is a cross-sectional view of a Fourth embodiment of abutton as shown in FIG. 15;

[0068]FIG. 16 is a sectional view of a repaired tendon using a firstembodiment of a button in accordance with the present invention;

[0069]FIG. 16A is a sectional view of a revised stitching procedure inaccordance with the invention of FIG. 15;

[0070]FIG. 17 is a sectional view of a repaired tendon using a secondembodiment of a button in accordance with the present invention;

[0071]FIG. 17A is a sectional view of a second embodiment of a button inaccordance with the present invention being swaged to a suture;

[0072]FIG. 17B is a top view of a second embodiment of a button inaccordance with the present invention;

[0073]FIG. 18A is a sectional view of a step in repair of a tendon usinga second embodiment of a suture in connection with the second embodimentof the button;

[0074]FIG. 18B is a sectional view of a step in repair of a tendon usinga second embodiment of a suture in connection with the second embodimentof the button;

[0075]FIG. 18C is a sectional view of a step in repair of a tendon usinga second embodiment of a suture in connection with the second embodimentof the button;

[0076]FIG. 18D is a sectional view of a step in repair of a tendon usinga second embodiment of a suture in connection with the second embodimentof the present invention;

[0077]FIG. 19 is a sectional view of a repaired tendon using a thirdembodiment of the present invention;

[0078]FIG. 19A is a sectional view of the button of FIG. 19;

[0079]FIG. 20A is a sectional view of a step in the repair of a tendonusing a fourth embodiment of the present invention;

[0080]FIG. 20B is a sectional view of a repaired tendon using the fourthembodiment of the present invention;

[0081]FIG. 21 is a sectional view of a tendon repair device inaccordance with the present invention used in connection with a boneanchor;

[0082]FIG. 22 is a sectional view of a second tendon repair device inaccordance with the present invention used in connection with a boneanchor;

[0083]FIG. 23A is a sectional view illustrating an alternativeembodiment of a tendon-to-bone repair apparatus in exploded form;

[0084]FIG. 23B is a sectional view similar to FIG. 23A, but showing theapparatus in assembled form attaching the tendon to the bone;

[0085]FIG. 23C is an enlarged sectional view of the apparatus as shownin FIG. 23B, specifically illustrating the compression of tendon fiberswithin a helical anchor of the present invention;

[0086]FIG. 24A is a sectional view of another alternative tendon-tobonerepair apparatus shown in exploded form;

[0087]FIG. 24B is a sectional view similar to FIG. 24A, but showing theapparatus in assembled form;

[0088]FIG. 24C is an enlarged sectional view of the apparatus shown inFIG. 24B;

[0089]FIG. 25A is a perspective view showing another alternativetendon-to-bone repair apparatus in exploded form;

[0090]FIG. 25B is a sectional view of another tendon-to-bone repairapparatus;

[0091]FIG. 26 is a sectional view illustrating yet another alternativetendon-to-bone repair apparatus also including a helical anchor systemaccording to the invention;

[0092]FIG. 27 is a top view showing incisions made in a finger to accessa tendon in accordance with additional aspects of the invention;

[0093]FIG. 28 is a top view similar to FIG. 27, but isolating the fingerto be repaired and showing transfixation of the tendon segments;

[0094]FIG. 29 is a perspective, schematic view showing initial steps ina tendon repair procedure in accordance with the invention;

[0095]FIG. 30 is an enlarged perspective view of the distal end of thetool shown in FIG. 29, illustrating the attachment of a helical anchorin accordance with the invention;

[0096]FIG. 31 is a perspective view showing the insertion of the helicalanchor within a tendon segment;

[0097]FIG. 31A is a partially cross sectioned, perspective viewillustrating a modified form of the anchor insertion tool shown in FIGS.29-31;

[0098]FIG. 32 is a perspective view similar to FIG. 31, but showing thesubsequent insertion of a retaining member into the tendon segment;

[0099]FIG. 33 is a partially fragmented sectional view similar to FIG.32, but showing the locking of the retaining member to the elongatetensile member;

[0100]FIG. 34 is a sectional view taken along line 34-34 of FIG. 33;

[0101]FIG. 34A is a sectional view similar to FIG. 34, but illustratingthe locking portion of the retaining member in a crimped or deformedcondition;

[0102]FIG. 35 is a perspective view of the tendon repaired in accordancewith the invention;

[0103]FIG. 36 is an enlarged sectional view schematically illustratingthe attachment of a tendon repair apparatus of this invention to thetendon fibers;

[0104]FIG. 37 is a plan view of an elongate tensile member, helicalanchor, and retaining member in accordance with another embodiment ofthe invention;

[0105]FIG. 37A is a perspective view of another embodiment of a helicalanchor constructed in accordance with the invention;

[0106]FIG. 37B is an elevational view of repair apparatus including thehelical anchor of FIG. 37A and a retaining member shown affixed to anelongate tensile member within a tendon in accordance with theinvention;

[0107]FIG. 38 is a partially sectioned plan view showing anotherembodiment of a helical anchor system;

[0108]FIG. 39 is an enlarged partially sectioned view similar to FIG.38, but illustrating the partial absorption of the retaining member inaccordance with this embodiment;

[0109]FIG. 40 is a schematic, sectional view showing an alternativeconfiguration of a helical anchor;

[0110]FIG. 41 is a schematic, sectional view of another alternativehelical anchor;

[0111]FIG. 42 is a schematic, sectional view of another alternativehelical anchor;

[0112]FIG. 43 is a partially sectioned view of another alternativerepair apparatus connected within a tendon;

[0113]FIG. 44A is a partially sectioned view of another alternativerepair apparatus in accordance with the invention;

[0114]FIG. 44B is a partially sectioned view similar to FIG. 44A, butshowing the partial absorption of the retaining member of thisembodiment;

[0115]FIG. 45A is a partially sectioned view showing another alternativeembodiment of a repair apparatus in accordance with the invention;

[0116]FIG. 45B is a partially sectioned view similar to FIG. 45A, butshowing partial absorption of the various components of the apparatus;

[0117]FIG. 45C is a partially sectioned view similar to FIG. 45B, butillustrating full absorption of the helical anchor and internalretaining member and partial absorption of the elongate tensile member;

[0118]FIG. 46 is a perspective view showing the partially assembledcondition of another alternative repair apparatus employing acompressible helical anchor;

[0119]FIG. 47A is a perspective view of an alternative apparatusemploying a compressible helical anchor with an integrated lockingmember;

[0120]FIG. 47B is a perspective view illustrating the embodiment of FIG.47A in a compressed and locked condition within a tendon;

[0121]FIG. 48A is a partially sectioned view of an alternativeembodiment for a locking member used to retain a helical anchor at aselected position along the elongate tensile member and showing thelocking member in an adjustable condition;

[0122]FIG. 48B is a partially sectioned view similar to FIG. 48A, butshowing the locking member in a locked condition;

[0123]FIG. 49A is a perspective view showing another alternative tendonrepair apparatus employing compressible, helical anchors in accordancewith the invention;

[0124]FIG. 49B is a perspective view similar to FIG. 49A, but showingthe apparatus fully implanted to repair the tendon;

[0125]FIG. 50 is a perspective view of another alternative embodimentemploying compressible, helical anchors in accordance with theinvention;

[0126]FIG. 51A is a partially sectioned view of another alternativetendon repair apparatus employing electromagnetic impulse energy tocollapse one helical member onto another and showing the uncollapsedcondition;

[0127]FIG. 51B is a partially sectioned view similar to FIG. 51A, butshowing the collapsed condition of the outer helical member and theattachment of a locking member within a tendon;

[0128]FIG. 51C is a partially sectioned view similar to FIG. 51B, butillustrating an alternative embodiment having a solid or non-helicalinner retaining member;

[0129]FIG. 52 is a schematic, perspective view showing a magneticimpulse generator operatively connected to a patient's finger forgenerating the required electromagnetic impulse in the embodiments ofFIGS. 51A and 51B;

[0130]FIG. 53A is a schematic, perspective view showing anotheralternative embodiment of a tendon repair apparatus employing acollapsible helical member;

[0131]FIG. 53B is a schematic perspective view showing an intermediatestep in the application of the collapsible helical member within thetendon;

[0132]FIG. 53C is a schematic perspective view similar to FIG. 53B, butshowing a subsequent step with the collapsible helical member beingcollapsed onto another helical member to compress tendon fiberstherebetween;

[0133]FIG. 54 is another alternative embodiment similar to theembodiment of FIGS. 53A-53C, but schematically illustrating anexpandable helical member for trapping tendon fibers with anotherhelical member;

[0134]FIG. 55 is a fragmented plan view showing another tendon repairapparatus employing a collet structure in accordance with the invention;

[0135]FIG. 56 is a perspective view of another collet-type anchorstructure shown in exploded form;

[0136]FIG. 57 is a partially sectioned view of the embodiment shown inFIG. 56, but illustrating the assembled condition of this embodimentwithin a tendon;

[0137]FIG. 58 is a perspective view of another alternative helicalanchor and internal retaining member showing a ratchet structure forpreventing counter-rotation of the retaining member;

[0138]FIG. 59 is a perspective view of another embodiment employing twohelical members with interlocking or intermeshing coils;

[0139]FIG. 60 is a perspective view of another alternative anchorstructure employing a flexible helical anchor wrapped around a retainingmember;

[0140]FIG. 61 is a graph illustrating a force/displacement curvecomparing a helical anchor repair apparatus of the invention against aconventional Kessler repair technique;

[0141]FIG. 62 is a perspective view of another alternative embodiment ofthe invention employing two helical anchors integrated with an elongatetensile member;

[0142]FIG. 63 is a partially sectioned view of a tendon retrieval deviceconstructed in accordance with the invention;

[0143]FIG. 64 is a perspective view showing use of the retrieval deviceof FIG. 63;

[0144]FIG. 65 is a perspective view illustrating an alternative doublehelix embodiment useful in the tendon retrieval device of thisinvention;

[0145]FIG. 66 is an end view taken along line 66-66 of FIG. 65;

[0146]FIG. 67 is a perspective view illustrating another alternativeanchor structure employing two crimpable anchor members, and an elongatetensile member;

[0147]FIG. 68 is a perspective view of a portion of a tool used to applythe anchor structure shown in FIG. 67;

[0148]FIG. 69 is a partially sectioned view illustrating the use of thetool to crimp the anchor members onto a tendon and the elongate tensilemember;

[0149]FIG. 70 is a sectional view taken generally along line 70-70 ofFIG. 67, but illustrating the crimped or deformed condition of the crimpmembers on the tendon tissue;

[0150]FIG. 71 is a sectional view taken generally along line 71-71 ofFIG. 67, but illustrating the crimped or deformed condition of the crimpmembers locked onto the elongate tensile member;

[0151]FIG. 72 is a plan view illustrating an alternative crimp-typeanchor structure employing a single crimp member and elongate tensilemember;

[0152]FIG. 73 is a sectional view taken generally along line 73-73 ofFIG. 72, but illustrating the crimped or deformed condition of the crimpmember onto the tendon tissue and around the elongate tensile member;

[0153]FIG. 74 is a sectional view taken generally along line 74-74 ofFIG. 72, but illustrating the crimped or deformed condition of the crimpmember onto the elongate tensile member;

[0154]FIG. 75 is a perspective view of a unitary anchor assemblycomprised of a helical anchor coupled for insertion with a core portionor tendon fiber retaining member;

[0155]FIG. 76 is a plan view showing the unitary anchor assembly of FIG.75 carried on an elongate tensile member and including a crimp member ata proximal end thereof;

[0156]FIG. 77 is a perspective view showing an insertion tool forinserting the assembly of FIG. 75 into a tendon or ligament;

[0157]FIG. 78 is a cross sectional view generally taken along thelongitudinal axis of the insertion tool shown in FIG. 77;

[0158]FIG. 78A is an enlarged view, partially cross sectioned, of thedistal end of the tool shown in FIG. 78;

[0159]FIG. 79 is an enlarged cross sectional view of the tool being usedto drive the unitary anchor assembly into a tendon or ligament;

[0160]FIG. 80 is a side elevational view schematically showing analternative pistol grip assembly for the insertion tool of FIG. 77allowing one-handed operation by a surgeon;

[0161]FIG. 80A is a fragmented end view of the pistol grip assembly ofFIG. 80 schematically illustrating the interaction between the rack andpinion drive;

[0162] FIGS. 81-87 are perspective views illustrating a tendon orligament repair method utilizing two unitary anchor assemblies and anelongate, flexible tensile member;

[0163]FIG. 88 is an enlarged perspective view showing the jaw portion ofa crimp tool and a crimp member each constructed in accordance withadditional aspects of the invention.

[0164]FIG. 89 is a perspective view of an anchor assembly removal toolin accordance with another aspect of the invention; and

[0165]FIG. 90 is an enlarged perspective view of the distal end of theremoval tool and the unitary anchor assembly of this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0166] Bone and Meniscus Repair Device

[0167] As shown in FIGS. 1-10, a novel device 10 for repairing afractured bone 12 is shown. The fractured bone repair device 10 hasthree primary parts, a flexible or rigid suture or filament 14, a firstbutton 16, and a second button 18. First button 16 is ideally identicalto second button 18. The suture or filament may be rigid or flexible,monofilament or multifilament.

[0168] As shown most particularly in FIG. 2, suture 14 has a first endand a second end 22. First end 20 of suture 22 is made rigid so as toallow the suture to be drilled through a fractured bone 12, as shown inFIG. 1. The rigid segment 20 is placed in a standard driver (not shown)which is well-known to one of ordinary skill in the art, most preferablya MicroAire Wire Driver. The rigid segment 20 ideally has a sharp point24 to allow for easier drilling.

[0169] A sheath 26 may also be provided for the filament 14 during thedrilling procedure and forms a part of this invention. The sheath 26would serve as an extension from the collet 28 of any of the well-knowndrilling tools. Two forms are contemplated. The first would use acollapsing sheath (not shown), such as an accordion pleat such that thesheath will buckle as the tool moves towards the bone 12. alternatively,a concentric spring 30 may be made of any of a variety of materials. Thematerial must be strong enough to withstand any punctures from smallbone fragments which may be displaced through the drilling procedure.However, it must be thin enough to allow its collapse as drillingprogresses. The material must also have sufficient heat resistance or asufficiently high melting point that it is unaffected by the heatgenerated by the drill. The sheath 16 will extend the full length of thedrilling tool from the collet 28 to fully protect surrounding tissues.

[0170] Optionally a short pin is located on the second end 22 of thesuture 14. This pin 32 may be used for hand drilling the bone 12.whether the bone 12 must be hand-drilled or may be drilled by machine isbased on a number of factors, all of which are well-known by these ofordinary skill in the art. The filament may alternately be passedthrough a pre-drilled hole in the bone 12.

[0171] Regardless of how the bone 12 is drilled, the method of operationof the bone repair device 10 is the same. The rigid second end 22 isdrilled from a first side 34 of a fracture 36 to a second side 38 offracture 36. The rigid second end 22 is then pulled such that the sutureportion 14 is within the bone 12. The purpose of the suture 14 beingoptionally flexible is that many bones which are fractured are small insize and are not easily aligned. In order to properly repair a bone,most particularly a small bone, using prior art technology, apractitioner must spend a large amount of time precisely aligning thefirst side 34 and second side 38 of fracture 36. If the suture used isflexible, the first side 34 and second side 38 need not be preciselyaligned, since the flexible suture 14 can bend at any point. While it isdesirable that first side 34 and second side 38 be somewhat aligned, itis not necessary to have as great a precision and much time can besaved.

[0172] The suture 14 is preferably a monofilament or multifilament wireor flexible polymer. The thickness of suture 14 depends on the size andlocation of the bone but, for small bones such as are in the hand, willfall within the range of 0.02 to 0.06 inches in diameter. The differingtensile strengths which will be needed for various bones and the tensilestrengths of various thicknesses are well-known to one of ordinary skillin the art.

[0173] Once the suture 14 has been drilled through bone 12, or passedthrough a pre-drilled hole, it extends completely through bone 12 fromthe first side 34 of fracture 36 to the second side 38 of fracture 36.The suture 14 must then be secured in order to hold the first side 34and second side 38 together until fracture 36 is healed. The suture issecured on each side 34, 36 by a button 16, 18. Because each button 16,18 is selected from the same group of possible designs, the designs aredescribed only in reference to first button 16. However, it will beunderstood that second button 18 may have a similar design.

[0174] As is most clearly shown in FIGS. 5 and 6, two types of buttons16 are preferred. FIG. 5 shows a button 16 which includes a flange 40which extends to or beneath the surface 44 of bone 12. FIG. 6 shows abutton 16 which includes a flange 42 resting on the surface 44 of bone12. Flanges 40, 42 serve to aid in distributing the tension load fromthe suture 14. Each button 16 has an inner surface 46, 48 which slidablycontacts and circumscribes suture 14. On the inner surfaces 46, 48 ofthe buttons 16 is one or more notches 50, 52. Notch 50 is formed suchthat it is an extension of flange 40, whereas notch 52 is formedseparately of flange 42. Because suture 14 is flexible and somewhatsoft, compared to buttons 16, a crimping tool (not shown) may be used topress inwardly on or crimp button 16 such that notches 50, 52 penetratesuture 14 and become secured to suture 14. In this way, the buttons 16,18 may become attached to suture 14.

[0175] An alternative button 16 is shown in FIGS. 7-10. This button 16is a locking spring washer. With such a button 16, the tension on thesuture 14 may be increased, but not decreased. This type of button 16locks by itself with no crimping tool required. The suture 14 ideallyincludes notches or grooves 54 to aid in the attachment of button 16 tosuture 14.

[0176] This method if ideally designed for use with bones in the handsor feet which are smaller and more delicate. However, the same inventionmay be used in connection with larger bones and may be particularlyuseful if a larger bone is broken into many smaller pieces. The diameterof the rigid segment, filament, and pin must be adjusted to effectivelyjoin the bone and fragment, especially if the bone and fragment arelarge.

[0177] Turning to FIG. 11, the same invention may also be used to repaira torn meniscus 56. The suture 14 (shown in dashed lines) is threadedthrough the meniscus 56 from a first side 58 to a second side 60 offracture or gear 62. While a meniscus 56 is typically referred to asbeing torn rather than fractured, the word “fracture” and all formsthereof should be understood to refer to both bones and to menisci inthe context of this invention for ease of understanding and vocabularyand to avoid confusion with the invention (described below) whichrelates to the repair of torn tendons. A first button 16 is attached toand circumscribes suture 14 on a first side 58 of the fracture 62 and asecond button 18 is attached to and circumscribes suture 14 on a secondside 60 of fracture 62. Buttons 16, 18 may have the same configurationas those described above or may resemble the tabs 144 as described intendon repair, FIGS. 17B.

[0178] Tendon Repair Device and Method

[0179] The method described may be used with any of the relevant buttonsin the present invention. The prior art method for repairing a torntendon is shown in FIG. 12, and involves making a single long incisionover the location of the torn tendon. The present invention (shown inFIG. 13) uses a device and method for repairing a torn tendon throughone or more skin incisions and two or more smaller incisions in thesheath, minimizing trauma to critical tissues. This invention may beused to repair either a tendon or a ligament. The term “tendon” as usedin the application should be understood to also encompass ligaments.

[0180] As shown in FIGS. 13 and 14, a surgeon makes a first incision 100in the skin 102 above the location of the tear 104 in the tendon 106. Itis noted that the skin above the tendon tear 104 may have already beenincised as in a laceration. If such is the case, only a small neateningof the incision may be relevant. The surgeon then makes a secondincision 108 on the first side 110 of the first incision 100. Thesurgeon also makes a third incision 112 on the second side 114 of thefirst incision. These incisions 100, 108, 112 preferably involve severaltransverse incisions or short “T” or “L” incisions. Additional small“window” incisions may be necessary to gain access for retrieval of thetendon end. The incisions 100, 108, 112 may also involve rolling thetendon or ligament sheath down a distance of about 3 mm. A needle 116(FIG. 14) is then threaded with a core suture or elongate tensile member118. The needle 1167 is preferably a swaged, large radius, non-cuttingneedle, which allows the needle 116 to penetrate the filamentous tendon106 without weakening it. For flexor tendons in the hand, the suture 118is preferably USP size No.1 or No.2 and is preferably made of amonofilament of polyester, stainless steel, or polyglactin 910, or otherhigh strength material. The needle 116 and attached suture 118 are theninserted into the tendon at the first side 112 of the tear 104. Theneedle 116 and the suture 118 travel down the center 120 of the tendon106, exiting at the second incisions 108. The surgeon then insertsneedle 116 and attached suture 118 at approximately the same center 120of the second side 124 of tear 104. The needle 116 and attached suture118 exit the tendon 104 through the third incision 112 on the secondside 114 of the tear 104. The suture 118 is then tightened such that thefirst side 122 of the tear 104 is drawn into abutting relationship tothe second side 124 of the tear 104, shown most clearly in FIG. 13. Asecond suture 118 may also need to be inserted in a similar fashion, aswill become clear from the following description. Once the suture 118has been properly placed, it must be secured in order to maintain theabutting relationship between first side 122 and second side 124 of tear104.

[0181] A first way of securing the suture is with a variety of buttons.A first embodiment is shown in FIG. 15 which shows the use of a slidinganchor button or body 126. A surgeon makes a stab or slit wound 128 inthe tendon 106 in an area generally under the second incision 108 madeon the first side 110 of the first incision 100. The sliding anchorbutton or body 126 slips onto the suture 118 and into the stab wound 128under the exterior surface 129 of tendon 106. The sliding anchor button126 has burrs 130 which serve to assist in holding sliding anchor button126 in place in tendon 106 once it reaches the desired location. Theburrs 130 are directed such that they are facing towards the tear 104and generally outwardly from the suture 118 and serve to reduce thepossible motion of sliding anchor button 126 and to distribute the axialload. In order to properly place the sliding anchor button 126, a tool132 should be used which is capable of keeping the exterior surface ofsliding anchor button 126 from coming into contact with tendon 106 priorto its correct placement. The tool 132 is important, since otherwise,the burrs 130 can tear or otherwise damage the tendon 106. Once thesliding anchor button 126 is in place, the tool 132 is retracted andsliding anchor button 126 is swaged to the suture 118 such that slidinganchor button 126 is attached to and at least partially circumscribessuture 118. FIGS. 15A-15D show a variety of possible forms for thesliding anchor button 126 in cross section. Each of these sliding anchorbuttons 126 has a width W. Preferably width W is about 2 mm. As can beseen in these FIGS., the sliding anchor button 126 can be configuredsuch that it slides onto suture 118 by being threaded, as in FIGS.15B-15D, or through a side slot as in FIG. 15A. Note also that in theseembodiments, the burrs 130 are directed radially outwardly from thesuture. Once the sliding anchor button 126 has been placed and swagedonto suture 118, the stab wound 128 is closed, preferably using acontinuous microsuture. As can be seen in FIG. 16A, the stitches used toclose the stab wound 128 may also penetrate to sliding anchor button 126and to optional holes 133. Once one sliding anchor button 126 has beenplaced, a surgeon can insert a second sliding anchor button in the sameway on the second side 114 of the first incision 100 below the thirdincision 112. During the installation of the second button 126, theabutting relationship between first side 122 and second side 124 of tear104 is assured by pre-tensioning the core suture 118 as the secondbutton 126 is attached. Tension may be applied by a special aspect oftool 132 or by manual means. The remainder of the procedure is the sameas that mentioned above. Once a button has been inserted on each offirst side 110 and second side 114, the tendon appears as is shown inFIG. 16. The incisions 100, 108, 112 may then be closed in any fashionknown in the art.

[0182] A second embodiment of securing buttons is shown in FIG. 17. InFIG. 17, two sutures 118 are used to hold first side 122 and second side124 in abutting relationship, as was mentioned above. In such a case, afirst suture 118 must be placed to one side of the center 120 of tendon106 and a second suture 118 must be placed to another side of the center120 of tendon 106. If this embodiment is used, no stab wound need bemade in the tendon 106. In this embodiment, once the suture is placed,the tab buttons 136 slide onto suture 118 until they reach the exteriorsurface 129. The suture 118 may be placed under greater tension bypushing tab buttons 136 such that they place some pressure on theexterior surface 138 of tendon 106. Once the tab buttons 136 have beenappropriately placed, they are swaged or crimped to suture 118 such thatthey are attached to and circumscribe at least a part of suture 118, asshown most clearly in FIG. 17A, by a swaging tool 140. Preferably, asshown in FIG. 17B, the tab button 136 has a circular shape, and includesa central portion 142 and a circular flange 144. The central portion 142and flange 144 include a slot 146 which allows tab button 136 to beeasily placed on suture 118. When tab button 136 is in place, the flange144 extends radially outwardly of the suture 118, shown most clearly inFIG. 17. The tab button 136 may include burrs 148 which extend generallyoutwardly from the suture 118 and serve to keep the tab buttons 136 inplace and distribute the axial load. Once the first tab button 136 hasbeen placed, a second, third, and fourth tab button 136 may be similarlyplaced using a similar method for each suture 118.

[0183] The tab button 136 may also be used with a different embodimentof the suture, as shown in FIGS. 18A-18D. In this embodiment, a splitand monofilament 150 is used. The split end suture 150 is inserted inthe center 120 of first side 122 of tendon 106, as shown by thedirection of the arrow in FIG. 18A. The split end suture 150 has a firstend 152. The first end 152 of split end suture 150 is divided into afirst part 154 and a second part 156. When split end suture 150 isinserted into tendon 106, the first part 154 and second part 156 arecontained within a cap 158 to retain first part 154 and second part 156together. Cap 158 has a sharp end 160 to allow cap 158 to penetratetendon 106. After the split end suture 150 and cap 158 reach anappropriate depth, the split end suture 150 is withdrawn in thedirection of the arrow shown in FIG. 18B. The split end suture 150 iswithdrawn only to just beyond the cap 158. The split end suture 150 isthen pushed in an inward direction as noted by the arrow in FIG. 18C.When the split end suture 150 is pushed, the first part 154 and secondpart 156 split apart and eventually break the exterior surface 138 oftendon 106. A fifth and sixth tab button 136 are then attached to thefirst part 154 and second part 156, respectively, such that fifth andsixth tab buttons 136 are attached to and at least partiallycircumscribe the first part 154 and second part 156, respectively. Thesame operation would apply on the second end (not shown) of the splitend suture 150, which is substantially the same as the first end 152 ofsplit end suture 150. The second end would simply be inserted into thesecond side 124 of tear 104. Other considerations which would berelevant are that the split end suture 150 should ideally be insertedsuch that half of it extends into each of first side 122 and second side124, and the first side 122 and second side 124 must be held in anabutting relationship, so that the entire length of the split end suture150 should be within the tendon 106. The tab buttons 136 used with thesplit end suture 150 are the same as those mentioned earlier and mayinclude flanges 144 or burrs 148.

[0184] Turning now to FIG. 19, a third embodiment of buttons is shown.The transverse button 162 is again used in conjunction with two sutures118, inserted as described above. The transverse button 162, as shown inFIG. 19A, is attached to an partially circumscribes a first suture 118and is swaged or crimped onto the first suture 118 with a swaging tool,such as tool 140. Another transverse button 162 is attached to andpartially circumscribes a second suture 118 and is swaged or crimpedonto the second suture 118 with a swaging tool, such as tool 140. Inthis embodiment, the transverse buttons 162 are attached to each otherby a telescoping mating pin 164. Attached to one of the transversebuttons 162 is the male portion 166 of the pin 164, and attached to theother transverse button 162 is the female portion 168 of the pin 164.The male portion 166 and the female portion 168 are pushed towards eachother through tendon 106. When male portion 166 and female portion 168reach each other, they ratchet and lock, thereby causing one of thetransverse buttons 162 to be attached to the other transverse button162.

[0185] The second method of securing the suture, instead of usingbuttons, is by using the suture itself. Turning to FIGS. 20A and 20B,the suture 170 includes barbs 172, which serve to secure the suture 170and distribute the axial load. When the barbed sutures 170 are insertedinto tendon 106 as described above, the sutures must be completelysurrounded by a cannula 174 or other protective device which serves tokeep barbs 172 from become attached to tendon 106 prior to properplacement. Once suture 170 is properly placed, as shown in FIG. 20A,cannula 174 is removed in any standard way. The barbs 172 will then keepthe suture 170 in place and keep first side 122 and second side 124 oftear 104 in abutting relationship.

[0186] An alternative installation process may be used in this inventionwhere a single suture has a needle on each end. In which case theneedles enter the central wound opening and each penetrates the severedend of the tendon; the two needles moving in opposite directions to exitat one of the window openings spaced from the wound. After each needleexits the suture is tightened and the tendon ends are drawn together bythe structure and procedural steps described above.

[0187] Device for Securing a Torn Tendon to a Bone

[0188] This invention relates to the use of a button as described abovein connection with a known bone anchor in order to secure a tendon to abone. Turning first to FIG. 21, a system is shown for attaching a bone200 and a tendon or ligament 202. A bone anchor 204 is installed in ahole 205 in the bone 200. Any of the standard bone anchors known in theart are suitable, as long as they are capable of being attached to aflexible suture 206. As shown in FIG. 21, a sliding anchor button 208 isattached to the flexible suture 206 and at least partially circumscribesthe flexible suture 206. The sliding anchor button shown in connectionwith the bone anchor 204 is inserted as was described earlier inconnection with the tendon repair device under the surface 210 of thetendon 202.

[0189] Turning now to FIG. 22, a second embodiment of the tendonboneanchor is disclosed. This embodiment is most preferably used when thetendon has a relatively thin cross-section, such as for exterior tendonsand most ligaments. Again, bone anchor 204 is installed in a hole 205 inthe bone 200. Any of the standard bone anchors known in the art aresuitable, as long as they are capable of being attached to a flexiblesuture 206. Also attached to the flexible suture 206 is a tab button212, which includes barbs 214 extending generally parallel with flexiblesuture 206 and radially outward on flange 211. Tab button 212 isattached to suture 206 as was described above such that tab button 212is attached to and at least partially circumscribes suture 206.

[0190] Another embodiment of a tendon to bone repair apparatus 250 isshown in FIGS. 23A-23C. In this embodiment, apparatus 250 includes anelongate tensile member 252 connected at one end with a bone anchor 254,such as by a knot or other stop member 252 a. Bone anchor 254 may be aconventional bone anchor configured for retainment within a bone 256.Apparatus 250 further includes a helical, compressible anchor 258 whichhas been rotated into a tendon or ligament 260. A retaining member 262,which may simply comprise a small button in this embodiment, receiveselongate tensile member 252, which may be a strong suture, and slidesdown onto tendon 260 as shown in FIG. 23B. A locking member, which maybe a crimp member 264 receives elongate tensile member 252 and slidesdown on top of retaining member 262 where upon it is deformed or crimpedand locked onto elongate tensile member 252 to hold apparatus 250together with a portion of tendon 260 held firmly against bone anchor254. As further detailed in FIG. 23C, the compressible, helical anchor258, which may have the tapered configuration as shown or otherconfigurations as detailed herein, traps fiber 266 of tendon 260 in agenerally sinusoid pattern between respective coils of anchor 258.

[0191] Another embodiment of a tendon to bone repair apparatus 270 isshown in FIGS. 24A-24C. Apparatus 270 also comprises an elongate tensilemember 272 connected with a bone anchor 274 again by way of a suitablestop, knot or other method. Bone anchor 274 is fixedly secured within abone 276. A helical anchor 278 is rotated into a tendon or ligament 280and is compressible. Unlike the previous embodiment, however, anchor 278is inserted generally with its axis in line with the length of tendon orligament 280 and anchor 278 is compressible generally along its length,as shown in FIG. 24B. When a retaining member 282 is received onelongate tensile member 272 and compressed onto tendon 280, against boneanchor 274, this will compress helical anchor 278 in a sideward manneras shown. A locking member 284, which again may be a crimp memberintegral or separate from retaining member 282, is then slid downelongate tensile member against retaining member 282 to hold apparatus270 in the position shown in FIG. 24B. As shown in FIG. 24C, elongatetensile member 272 extends through the center of helical anchor 278generally along the lengthwise axis thereof and from one end to theother, although the helical anchor may intertwine with the coils ofanchor 274 in other manners as well. Fibers 286 of tendon 280 willextend between the coils of anchor 274 in a generally sinusoidal patternthus firmly trapping anchor 274 within tendon or ligament 280.

[0192] Another embodiment 290 is shown in FIG. 25A. Apparatus 290comprises an elongate tensile member 292 suitable connected to a boneanchor 294 by way of a knot or stop member 292 a or another method.Apparatus 290 further includes a helical anchor 298, which again ispreferably compressible, and received on elongate tensile member 292. Aretaining member 302 is also received on elongate tensile member 292 asshown in FIG. 25A. Locking members, in the form of projections 294 a,294 b, 294 c, are disposed on bone anchor 294 and register in receivingslots 302 a, 302 b, 302 c within retaining member 302. Apparatus 290 isused in a manner similar to apparatus 250 shown in FIGS. 23A-23C, exceptthat after helical anchor 298 has been rotated into a tendon, retainingmember 302 is pushed or rotated simultaneously with helical anchor 298if anchor 298 is attached to retaining member 302, and locked onto boneanchor 294 through the receipt of projections 294, 294 b, 294 c withinthe respective slots 302 a, 302 b, 302 c. The insertion and retainmentof helical anchor 298 within a tendon or ligament may advantageouslyoccur in a single surgical step if helical anchor 298 is connected forrotation with retaining member 302. In this case, for example, rotationof retaining member 302 can simultaneously rotate helical anchor 298into a tendon or ligament and lock the assembly onto bone anchor 294.

[0193] Another embodiment of a tendon to bone repair apparatus 310 isshown in FIG. 25B. In apparatus 310, an elongate tensile member 312 isagain connected with a bone anchor 314 by a suitable method, such as aknot 312 a. Bone anchor 314 is securely affixed, such as by a threadingaction within a bone 316. A helical anchor 318 is received on elongatetensile member 312 and is adapted to be rotated into a tendon 320.Helical anchor 318 is connected to a retaining member 322 in thisembodiment either through a mechanical or integral connection. A lockingmember 324, which again may comprise a crimp member, is integrallyformed with retaining member 322 in this alternative embodiment. In itsattached configuration, apparatus 310 is very similar to apparatus 250shown in FIGS. 23A-23C with helical anchor 318 being trapped withintendon 320 and fibers thereof being generally sinusoidally trappedbetween the coils of anchor 318.

[0194] Another alternative tendon bone repair apparatus 330 is shown inFIG. 26. Apparatus 330 includes an elongate tensile member 332 connectedin a suitable rigid manner to bone anchor 334 such that it may be placedinto tension. Bone anchor 334 is again affixed securely within a bone336. A helical anchor 338 is rotated into a tendon or ligament 340 in amanner similar to the embodiment, for example, of FIGS. 23A-23C. In thisembodiment, however, a retaining member 322 is provided for at leastpartial insertion within anchor 338 as shown in the assembled conditionof FIG. 26. This traps fibers between retaining member 342 and the coilsof anchor 338. Once retaining member 342 is securely received withinanchor 338, a locking member 344, which may be integral to or separatefrom retaining member 342, is slid onto elongate tensile member 332against retaining member 342 and crimped onto tensile member 332. Itshould be appreciated that, although the elongate tensile members of theembodiments shown in FIGS. 23A-26 are flexible sutures, these may alsobe more rigid tensile members, such as members made of biocompatiblemetals or they may alternatively be formed of absorbable materials. Oneor more of the other elements of these tendon to bone repair apparatusmay also be formed of absorbable materials.

[0195] Alternative Tendon Repair Apparatus

[0196] The invention contemplates further embodiments of tendon-to1tendon or ligament-to-ligament repair apparatus. For simplicity, onlythe term “tendon” is used herein at various points. A review of thegeneral procedure is appropriate with reference first to FIGS. 27 and28. When faced with repairing a severed or otherwise damaged tendon, thesurgeon must make an incision to repair the severed or damaged tendon.FIG. 27 shows the actual laceration site 350 of a finger 351 and theaugmented incision 352 made by the surgeon to gain access. After theincision has been made the skin flaps 354 are reflected back for fullvisualization of the damage. The surgeon will retrieve the proximaltendon segment 356 of the damaged tendon through a triangular windowaccess incision 358 made in the tendon sheath 360. The triangularincision 358 helps prevent the end of the proximal tendon segment 356from catching on window incision 358 as it is retrieved. The distalsegment 362 of the damaged tendon will also be retrieved in the samemanner. Once the tendons ends have been retrieved as shown in FIG. 28,they are held in place temporarily with transfixation needles 364. Thefunction of these needles is to hold the tendon segments 356, 362together without damaging the tips of the tendon which must be kept astrauma free as possible to promote a good repair.

[0197]FIG. 29 shows the transfixed tendon ends 370, 372 without thesurrounding anatomy and transfixation needles 364. In accordance withthe invention, access incisions 374 of about 0.5 cm in length is madeapproximately 2-3 cm from the lacerated ends 370, 372 of the tendon.Preferably, a No. 2 suture 376 is placed in through the access incision374 of the proximal tendon segment 356 out through the lacerated end 372of the proximal segment 356 into the lacerated end 370 of the distaltendon segment 362 and out through the access incision 374 of the distaltendon segment 362. Once the suture 376 is placed lengthwise through thetendon with a needle 378, the surgeon places an anchor system of thisinvention into the tendon body.

[0198]FIG. 31A illustrates an alternative tool 392′ for rotating helicalanchor 390 into the tendon. Tool 392′ includes a flexible, hollow shaft396′, however, in this embodiment shaft 396′ is contained within ahollow sheath 397 which is also flexible. Anti-rotation structure 399 isdisposed within sheath 397 and may be actuated between a retractedposition within sheath and an extended position as shown in FIG. 31A. Inthe illustrative example shown, structure 399 comprises spikes thatflare outwardly into tendon segment 356 to prevent rotation of tendonsegment 356 as flexible shaft 396′ is rotated, while sheath 397 remainsstationary. This prevents the tendency of the tendon from rotating withthe anchor as the anchor is rotated into place.

[0199] Referring now to FIGS. 29-31, a first alternative helical anchorrepair apparatus is shown being inserted into tendon segments 356, 362.

[0200] This includes a first helical anchor 390 being applied with atool 392 having a handle 394 and a flexible shaft 396. It will beappreciated that many different tool configurations may be used in placeof tool 392. A distal end of tool 392 includes an anchor mountingportion 398 having a blunt tip. A trailing end 400 of helical anchor 390includes a drive portion received in an aperture 402 associated with ahub 404 of end portion 398. Anchor 390 further includes a leading end406 which may be formed as either a sharpened or blunt tip. Anchormounting portion 398 further includes a suitable aperture (not shown)along its length such that elongate tensile member or suture 376 may bethreaded therethrough as shown in FIG. 29. Thus, anchor 390 isreleasably attached to end portion 398 and elongate tensile member 376extends through the center of helical anchor 390.

[0201] Tool 392 is used to rotate helical anchor 390 like a screw intotendon segment 356 through access incision 374 and rotated into place asshown in FIG. 31. At this point, the surgeon pulls back on tool 392thereby releasing mounting end portion 398 from helical anchor 390. Atthis point, and as shown in FIG. 32, a retaining member 410 is installedat least partially within helical anchor 390. An installation tool 412is used to grasp retaining member 410, which is slidably received onelongate tensile member 376. The surgeon slides retaining member 410along elongate tensile member or suture 376 until reaching the positionshown in FIG. 33. This traps and compresses the collagen fibers of thetendon between retaining member 410 and helical anchor 390 in a mannerto be discussed further below. When retaining member is firmly situatedwithin helical anchor 390, the surgeon can deform a rear crimpableportion 414 as depicted in FIGS. 33, 34 and 34A. In this regard, FIG. 34shows rear crimpable portion 414 in an uncrimped state, while FIG. 34Ashows crimpable portion 414 in a crimped position securely affixed toelongate tensile member 376. This fixes the anchor structure, comprisinganchor 390 and retaining member 410 securely to the fibers within tendonsegment 356 and also affixes the anchor structure to the desiredlocation on elongate tensile member suture 376. Upon completion of thisstep, the surgeon moves on to tendon segment 362 and applies a similarprocedure to affix a second helical anchor 420 and retaining member 422to the suture 376 through access incision 374. Prior to crimpingretaining member 422 onto suture 376, the surgeon may adjust thedistance between tendon ends 370, 372 by sliding the anchor structure420, 422 along suture 376 while applying a force, such as with tool 412,to move the assembly 420, 422 along with tendon segment 362 toward theopposite segment 356. When the desired repair position is reached, forexample, with tendon ends 370, 372 approximately 1-2 mm apart, thesurgeon crimps retaining member 422 to suture 376 in a manner similar toFIG. 34A.

[0202] It will be understood that other manners of locking a retainingmember, such as members 410 and 422, in place may be used instead ofcrimp members or deformable portions of the retaining members. As shownin FIG. 35, opposite ends of suture 376 are cut at locations close tothe respective retaining members 410, 422 and access incisions areclosed, such as by using sutures 424, 426 or another acceptable method.Finally, a running suture 428 is placed at the junction of tendon ends370, 372 or, again, another acceptable connection method may be used.

[0203]FIG. 36 illustrates an alternative helical anchor 440 andretaining member 442 connected to elongate tensile member or suture 376and held within tendon segment 356. FIG. 36 further illustrates thebenefits of the invention in more detail. In this regard, fibers 244,which extend lengthwise within tendon segment 356 have been engagedwithin coils 446 of anchor 440 as anchor 440 was rotated into place aspreviously described. This engagement will occur generally in asinusoidal pattern as shown, although the number and density of fibers444 has been drastically reduced in the figure for clarity. Retainingmember 442 may also have a discontinuous outer surface 448, as shown,such as a serrated surface as shown in cross section in this view. Thiswill further help retain the tendon fibers 444 between retaining member442 and helical anchor 440 and prevent retaining member 442 from backingout of helical anchor 440. An integral crimp member 450 is disposed on atrailing end of retaining member 442. A separate crimp member or otherlocking structure may be used in its place.

[0204]FIG. 37 discloses another alternative embodiment including ahelical anchor 460 and a retaining member 462 adapted to be fixed intoplace on elongate tensile member 376 in a manner generally similar tothe previous helical anchor embodiments. In this embodiment, retainingmember 462 includes a discontinuous outer surface in the form of athreaded surface 464 which provides an anti-backout function and willallow gripping of the tendon fibers as retaining member 462 is rotatedinto helical anchor 460. A crimp member 466 may be provided to fixretaining member 462 in place as previously described. Also, suitableflats 468 may be provided for tool engagement allowing rotation ofretaining member 462.

[0205]FIGS. 37A and 37B respectively illustrate another alternativeembodiment of a helical anchor 460′ and an anchor structure comprising ahelical anchor and retaining member 460′, 462′. Helical anchor 460′ hasopposite, tapering but blunt ends 460 a′, 460 b′ to allow insertion intoa tendon at either end 460 a′ and 460 b′. The blunt ends 460 a′, 460 b′will spread the tendon tissue during entry as opposed to tearing,slicing or otherwise damaging the tissue. Other sharpened or blunt endconfigurations may be used as well. Retaining member 462′ includes aslot 462 a′ at a trailing end for engagement with a rotating tool, and atapered leading end 462 b′ for entry into helical anchor 460′. An outersurface 462 c′ is discontinuous in a convoluted, generally helicalmanner to generally register with the coils of helical anchor 460′.Thus, fibers 444 will be retained during use in a generally sinusoidalmanner between the coils of helical anchor 460′ and the convoluted outersurface 462 c′ of retaining mmber 462′. Finally, retaining member 462′includes a central aperture 463 along its longitudinal axis forreceiving an elongate tensile member such as the previously describedsuture 376.

[0206]FIGS. 38 and 39 illustrate another alternative embodimentutilizing a modified elongate tensile member 376′ having barb or ratchetstructure 470. Ratchet structure 470 is engageable with an internalportion 472 of a retaining member 474. Therefore, as retaining member474 is moved into helical anchor 460, the interaction of structures 470and 472 will prevent retaining member 474 from backing out. Thistherefore provides an alternative locking structure for holdingretaining member 474 against anchor 460 with tendon fibers trapped andcompressed therebetween. As further shown in FIG. 39, retaining member474 may be formed from absorbable material, such as polyglycolic acid orpolyglyconate. As retaining member 474 is absorbed, more tensile forcewill be experienced at the repair site as retaining member 474 will tendto move slightly further into helical anchor 460. This gradual increasein tensile stress at the repair site will promote faster and strongerhealing.

[0207] FIGS. 40-42 illustrate three potential alternative embodiments ofhelical anchors, namely, anchors 480, 482 and 484. As currentlycontemplated, the anchors will be tapered from a larger diameter at atrailing end to a smaller diameter at a leading end to assist inthreading the anchor into the tendon tissue. However, it will beunderstood that many other configurations are possible as well with afew of the possibilities illustrated in FIGS. 40-42. In FIG. 40, helicalanchor 480, shown in cross section, has a varying diameter along itslength and an axis 486 which is not parallel to elongate tensile member376 during use. Also, tensile member 376 travels partially within thecoils of anchor 480 and partially outside of the coils. In FIG. 41, asimilar configuration is shown, except that tensile member 376 iscontained entirely within helical anchor 482 and anchor 482 has coils ofapproximately equal diameter along its length. FIG. 42 illustrates ananchor 484 that converges in diameter centrally from each end.

[0208]FIG. 43 illustrates another embodiment of the invention whereinthe elongate tensile member 376 is retained by a wedging action betweena retaining member 490 and a helical anchor 492. Retaining member 490may have a serrated or otherwise discontinuous outer surface 494 forassisting in wedging and retaining elongate tensile member 376 againsttendon fibers 496 and helical anchor 492. Again, the number and densityof fibers 496 is drastically reduced in FIG. 43 for clarity.

[0209] Another embodiment of the invention is shown in FIGS. 44A and44B. This embodiment is similar to the embodiment shown in FIG. 36 butillustrates the effect of forming retaining member 442 ′ from absorbablematerials. The effect is similar to the effect described above inconnection with FIGS. 38 and 39. That is, as retaining member 442′absorbs into the tendon, the repair site will experience a greateramount of tensile force during physical therapy or other motion of thetendon. Again, this will speed the healing process and result instrengthening the repair site.

[0210] FIGS. 45A-45C illustrate a further use of absorbable materialsfor helical anchor 440′, retaining member 442′ and elongate tensilemember 376″. In this embodiment, each of the elements will graduallyabsorb as shown progressively in the figures such that the function oftransferring more tensile stress to the repair site is accomplished andsuch that the repair apparatus as a whole will fully or substantiallyabsorb into the tendon after it has fulfilled its repair function. Inthis embodiment, the absorption rates of the different components may bevaried by using different materials. For example, retaining member 442′may be formed to absorb faster than elongate tensile member 376″ oranchor 440′ such that tension is, at first, gradually transferred to therepair site. Then, after full healing has taken place, the remainingcomponents can absorb into the tendon, removing all tensilereinforcement from the repair.

[0211]FIG. 46 illustrates an alternative embodiment of the inventioncomprising a compressible, helical anchor 500 receiving elongate tensilemember 376 and adapted to be retained in place within a tendon through acompressing action brought about by a suitable structure on elongatetensile member 376, such as a separate crimp member 502 or an integralor attached crimp member associated with helical anchor 500 as shown inFIGS. 47A and 47B. It will be understood that many other potentiallocking structure may be substituted for crimp members 502 and 504 aslong as the ultimate function of compressing helical anchor 500 isaccomplished. As shown in FIG. 47B, when crimp member 502 or 504 isfixed onto elongate tensile member 376, an elongate tensile member 376is pulled in the direction of arrow 506, toward the repair site, thecoils of helical anchor 500 will compress and securely engage the tendonfibers therein. In this manner, helical anchor 500 will be locked ontotendon fibers 508 and the tendon segments may be pulled together at therepair site in the manner described above.

[0212] An alternative crimp member is shown in FIGS. 48A and 48B. Inthis embodiment, crimp member 520 comprises first and second movableportions 522, 524 connected at a central portion 526. Crimp member 520may be received on and slid along elongate tensile member 376 inabutting relation to a trailing end portion 500 a of helical anchor 500and crimped against elongate tensile member 376 by squeezing ends 528,530 together as shown in FIG. 48B. A nub 532 and opposing recess 534 maybe provided to help retain crimp member 520 fixed against elongatetensile member 376. Opposite ends 536, 538 may bear against trailing endportion 500 a. In this manner, the assembly may be used, for example, inthe manner described with respect to FIG. 47B.

[0213] An alternative embodiment of a repair apparatus 550 incorporatingan elongate tensile member 552 and a pair of compressible, helicalanchors 554, 556 is shown in FIGS. 49A and 49B. In this embodiment,elongate tensile member 552 is initially comprised of two suturesegments 552 a, 552 b. As with the other embodiments this may be USP No.2 suture. As in the previous embodiments, a crimp member 558, 560 may beassociated with each compressible, helical anchor 554, 556 or therespective tensile member segments 552 a, 552 b may be connected withanchors 554, 556 in another suitable manner. The two tensile membersegments 552 a, 552 b are threaded through a central crimp member 562after being introduced through respective tendon segments 564, 566preferably through respective proximal and distal windows in the tendonas described above. Tensile member segments 552 a, 552 b are pulled tautthrough central crimp member 562. This simultaneously compresses helicalanchors 554, 556 and pulls tendon segments 564, 566 together to a repairposition as shown in FIG. 49B. At this time, a conventional runningsuture 568, or optionally an adhesive or other acceptable method, may beused to connect tendon segments 564, 566 together at the repair site.

[0214] Another embodiment of a tendon repair apparatus 570 is shown inFIG. 50. Apparatus 570 utilizes an elongate tensile member 572, such asa suture comprised of one suture segment looped through a plurality of,for example, four compressible, helical anchors 574, 576, 578, 580. Inthis embodiment, separate crimp members at each helical anchor may beeliminated as the suture itself will pull each of the helical anchors574, 576, 578, 580 to a compressed position as the two suture ends 572a, 572 b are pulled through central crimp member 582. As in theembodiment of FIG. 49A and 49B, pulling the two ends 572 a, 572 bthrough central crimp member 582 will simultaneously compress eachhelical anchor 574, 576, 578, 580 and bring tendon segments 584, 586together to a repair position at which points ends 572 a, 572 b may becut and a running suture or other final attachment method may beemployed by the surgeon to complete the repair.

[0215]FIGS. 51A, 51B and 52 illustrate an alternative manner ofemploying helical anchors to connect a repair apparatus to tendons andligaments. Specifically, this system employs first and second helicalmembers 590, 592 with at least one of the helical members 590, 592 beingmovable toward the other to trap and compress tendon or ligament fibers594 of the tendon or ligament 596 therebetween. As with otherembodiments of the invention, a suitable locking member, such as a crimpmember 600, may be used to connect elongate tensile member 598 formovement with anchor members 590, 592 such that tendon segment 596 maybe pulled and placed under tension with elongate tensile member 598. Inthe specific embodiment shown in FIGS. 51A, 51 B and 52, a magneticimpulse generator 602 is connected with a magnetic impulse supply unit604 disposed around the patient's finger 606. Analogous systems areavailable from Maxwell Magneform® in San Diego, Calif. When a magneticimpulse or impulses are supplied with generator 602 this will collapsefirst helical member 590 onto second helical member 592. To accomplishthis, for example, first helical member or outer helical member 590 maybe formed from a magnetic metal material, while second helical member orinner member 592 is formed from a non-magnetic material and, therefore,does not deform through the application of an electromagnetic impulse.As with several other embodiments of this invention, this again employsthe general technique of providing two portions of a tendon or ligamentanchor structure with at least one portion being movable toward theother portion to trap and compress tendon or ligament fiberstherebetween. Furthermore, prior to crimping of member 600, crimp member600 may be moved along elongate tensile member 598, after collapsingouter helical member 590 such that tendon segment 596 is moved to theappropriate repair position at which point the surgeon may crimp member600 to retain tendon segment 596 at the repair position.

[0216]FIG. 51C illustrates another alternative embodiment similar inconcept to the embodiment of FIGS. 51A and 51B. In this embodiment,however, an inner retaining member 462′ can comprise a solid coremember, as opposed to a helical member. Retaining member 462′ can beformed of absorbable or non-absorbable materials. Retaining member 462′is preferably threaded over elongate tensile member 598 after insertionof outer helical member 590 within tendon 596. Initially, outer helicalmember 590 is in an uncollapsed or expanded state, as shown in phantomlines, and receives both elongate tensile member 598 and retainingmember 462′. After insertion of retaining member 462′, one or moreelectromagnetic impulses are applied to collapse outer helical member590 generally to the position shown in solid lines thereby compressingtendon fibers 594 between outer helical member 590 and inner retainingmember 462′. As further shown, retaining member 462′ may include anouter discontinuous surface, such as a convoluted or threaded surface462 c′ to help retain, grip or otherwise engage fibers 594. Asnecessary, a locking member 600′ may be crimped or otherwise locked ontoelongate tensile member 598 and against retaining member 462′ to lockthe anchor structure, comprising retaining member 462′ and helicalmember 590, to elongate tensile member. It will be appreciated thatlocking member 600′ may not be necessary in any given application of theinventive concepts.

[0217] FIGS. 53A-53C illustrate another alternative embodiment of arepair apparatus 610 employing generally similar concepts to theembodiment of FIGS. 51A and 51B. Specifically, in FIG. 53A, apparatus610 is employed in a tendon segment 612 and again includes an elongatetensile member 614 connected with a first helical member 616 by asuitable connector 618. A second helical member 620 is initiallycontained in a hollow, helical carrier 622. Carrier 622 has a diameter“D” which is greater than the diameter “d” of second helical member 620.Thus, as second helical member 620 is rotated into carrier 622, member620 elastically expands to the shape of carrier 622 and is thereforeinitially disposed or carried at a diameter “D”. As further shown inFIG. 53B, as carrier 622 and second helical member 620 are rotated intotendon segment 612 through an access incision 624, carrier 622 isrotated over first helical member 616. As further shown in FIG. 53C, ascarrier 622 is counterrotated or rotated in a reverse direction, secondhelical member 620 is left behind and resiliently contracts orcompresses around first helical member 616 thereby trapping tendonfibers (not shown) between member 616 and member 620. It may benecessary for the surgeon to hold second helical member 620 stationarywhile counter-rotating carrier 622 as shown in FIG. 53C. Upon removal ofcarrier 622, elongate tensile member 614 will be effectively connectedto tendon segment 612 and may be placed under tension while, forexample, pulling tendon segment 612 to a repair position as previouslydescribed.

[0218]FIG. 54 illustrates an alternative embodiment of an apparatus 630essentially employing a reverse technique as compared to the embodimentof FIGS. 53A-53C. In this embodiment, a hollow, helical carrier 632 hasa smaller outer diameter “d”, than the respective diameters “D”associated with first and second helical members 634, 636. Elongatetensile member 614 may be suitably connected to first helical member634, such as through the use of a suture knot 614 a. In this embodiment,first helical member 634 is rotated into tendon segment 612 in one ofthe previously described manners and, similarly, carrier 632, whichcontains second helical member 636 in a resiliently compressed state isrotated into the center of first helical member 634. With second helicalmember 636 held stationary, helical carrier 632 is counter-rotated, asshown in FIG. 54, leaving second helical member 636 to resilientlyexpand to its normal diameter “D” thereby trapping tendon fibers (notshown) between first and second helical members 634, 636. With carrier632 removed, and helical members 634, 636 securely affixed to the tendonfibers, elongate tensile member 614 may be placed under tension and usedto pull tendon segment 612 to a repair position as previously described.It should be appreciated that the respective diameters of helicalmembers 616, 620 and 634, 636 may vary within the same anchor system.That is, helical anchor 616 may be slightly smaller or larger thanhelical anchor 620 and helical anchor 634 may be slightly smaller orlarger than helical anchor 636 while retaining the ability to traptendon fibers therebetween. Again, each of these anchor structuresemploy at least one moveable anchor portion to trap fibers betweenitself and another anchor member.

[0219]FIG. 55 illustrates another alternative apparatus 640 comprised ofa helical anchor 642 and elongate tensile member 644 and a retainingmember 646. These three elements operate together similar to previousembodiments in that helical anchor 642 and retaining members 646 areeach initially slidable along elongate tensile member 644. Elongatetensile member 644 may again be a flexible suture, semi-flexible orrigid tensile member. In this embodiment, retaining member 646 acts as acollet structure and includes one or more slots 648 extending from aleading end 646 a. Also, retaining member 646 may include adiscontinuous outer surface 650, such as a surface having a generallythreaded configuration. It will be appreciated that, as retaining member646 is rotated into helical anchor 642, tendon or ligament fibers (notshown) will be trapped between surface 650 of retaining member 646 andthe inner surfaces of helical anchor 642. At the same time, the colletstructure at the leading end of retaining member 646 will compress dueto the slot or slots 648 and will clamp against elongate tensile member644 to retain the assembly fixed on elongate tensile member 644.Retaining member 646 may be formed of a material that allows the leadingend to plastically deform and clamp onto elongate tensile member 644.

[0220] A related embodiment utilizing collet-like structure is shown inFIGS. 56 and 57. In this embodiment, an apparatus 660 generally includesa helical anchor 662 and a two-piece retaining member structurecomprised of inner and outer retaining elements 664, 666. Anchor 662 andretaining elements 664, 666 are initially slidable along an elongatetensile member 668. One or more slots 670 are formed at a leading end ofinner retaining element 664 and one or more slots 672 are formed at atrailing end of outer retaining element 666. Again, an outer surface 674may be discontinuous to help trap tendon fiber between outer retainingelement 666 and helical anchor 662 as described below. A review of FIG.57 will indicate the function of various elements shown in FIG. 56. Moreparticularly, after helical anchor 662 has been rotated into a tendonsegment 676, the surgeon slides inner retaining element 664 into helicalanchor 662 to trap tendon fiber 678 between outer surface 674 andhelical anchor 662. To lock the assembly into place and to expand outerretaining element 664 to further lock the tendon fiber 678, the surgeonslides inner retaining element 664 or, alternatively, rotates innerretaining element 664 into outer retaining element 666. Thissimultaneously expands outer retaining element 666 through the action ofslots 672 and contracts the leading end of inner retaining element 664through the action of slots 670 and a tapered inner surface 680 of outerretaining element 666. Thus, in the position shown in FIG. 57, apparatus660 is ready for use in accordance with the inventive concepts to repairthe tendon by placing tendon segment 676 into tension using elongatetensile member 668.

[0221]FIG. 58 illustrates an alternative apparatus 690 again employing ahelical anchor member 692 and a retaining member 694 each connected forsliding movement along an elongate tensile member 696. Retaining member694 may again include a drive portion 698 for allowing retaining member694 to be rotated into helical anchor 692. This embodiment illustrates amanner of preventing counter-rotation or backout of retaining member 694after installation within a tendon. In this regard, a ratchet structure700 is disposed at a trailing end portion of retaining member 694 forengaging a trailing end 692 a of helical anchor 692. As retaining member694 is rotated into helical anchor 692, ratchet structure 700 willengage trailing end 692 a to prevent counter-rotation of retainingmember 694.

[0222]FIG. 59 illustrates two helical anchors 702, 704 in which thehelical coils are interlocked or intertwined. This may be used in thevarious embodiments of this invention to better interlock the helicalanchor structure with the tendon fibers. For example, while one helicalanchor 702 may be initially rotated into the tendon and, subsequently,the second helical anchor 704 may be rotated in an interlocking fashionwith the first helical anchor 702. The assembly is then used inaccordance with the invention, and with one or more elongate tensilemembers or tensile member segments to place a tendon under tensionduring a repair as generally described herein. Alternatively, the coilsof anchor 702, 704 may interlock in a lateral direction as shown in FIG.59 without actually having the coils of one anchor rotate into the coilsof the other anchor.

[0223]FIG. 60 illustrates an alternative apparatus 710 in which aflexible helical anchor 712 is wrapped around an internal retainingmember 714. Helical anchor 712 may be formed from suture material, forexample, that is one in the same with an elongate tensile member 716used in accordance with the inventive concepts or which is separate froman elongate tensile member which may extend through a centrallongitudinal aperture (not shown) within retaining member 714. Leadingand trailing hook members 718, 720 may be provided for guiding helicalanchor 712 at the ends of retaining member 714.

[0224]FIG. 61 illustrates force vs. displacement curves for helicalanchor apparatus of the present invention as compared to conventionalKessler repair techniques. The helical anchor repair apparatusrepresented in FIG. 61 corresponds with the embodiment of FIG. 37B. TheKessler stitch techniques were performed with 3-0 Vicryl sutures andeach repair was placed in porcine tendon of approximately 5 mm diameter.The graph demonstrates that the Kessler stitches allow displacement orgapping between the tendon segments at low levels of tensile force ascompared to the helical anchor structures and elongate tensile member ofthe present invention. In other words, the helical anchors of thepresent invention will sustain much higher levels of tensile forcewithout significant amounts of gapping occurring between the tendon endsas compared to the Kessler stitch technique. For this reason, a patientwho has undergone a repair using the present invention can undergo moreimmediately and vigorous physical therapy than a patient having aKessler stitch repair. Ultimately, the patient will experience a quickerrecovery time and more mobility proximate the repair site using thepresent invention.

[0225]FIG. 62 illustrates an alternative embodiment of the inventionwherein an integral apparatus 730 comprises a tensile member 732 andopposite helical anchors 734, 736. Anchors 734, 736 are coiled inopposite directions such that rotation of apparatus 730 in a singledirection will cause helical portions 734, 736 to each rotate intorespective opposed tendon segments 738, 740. Apparatus 730 may be formedwith various degrees of rigidity or flexibility suitable for the repairsite. Retaining members (not shown) in accordance with the invention maybe used to hold anchors 734, 736 securely to the tendon tissue.

[0226] The concepts employed in the helical anchor based repairapparatus of the present invention may also be employed in a tendonretrieval device 750 as, for example, shown in FIGS. 63 and 64.Retrieval device 750 may be inserted into a tendon sheath through awindow 752, which may be triangular-shaped as previously described.Retrieval device 750 more specifically comprises a rotatable shaft orrod 754 having a helical retrieving member 756 at one end and arotatable knob 758 connected at an opposite end. Shaft or rod 754 iscontained within a hollow inner core 760 which, in turn, is containedwithin an outer core 762. Anti-rotation members 764, 766 are preferablyprovided within hollow outer core 762 and may be actuated fromnon-operative positions to the operative positions shown in FIG. 63.This is accomplished by reciprocating a knob 768 back and forth. Whenknob 768 is moved to the left, as viewed in FIG. 63, this extendsanti-rotation members 764, 766 into the tendon sheath 770 to preventrotation thereof as rotatable knob 758 is subsequently rotated and movedinwardly to rotate helical member 756 into tendon end 772. Once helicalmember 756 is fully rotated into tendon end 772, knob 758 may be pulledto the right, as viewed in FIG. 63, to retrieve tendon end 772.

[0227] It will be appreciated that retrieval device 750 may be modifiedin many different manners consistent with the concepts disclosed herein.As one example, device 750 may further include an internal retainingmember which may be inserted into helical member 756 to retain tendonfibers therebetween as previously discussed above with respect totendonto-bone and tendon-to-tendon repair apparatus. Another potentialalternative is shown in FIGS. 65 and 66 in which inner and outer helicalretrieving members 776, 778 are employed to counter-rotate into tendonend 772. Suitable actuation structure (not shown) will be employed tocounter-rotate helical members 776, 778, thereby eliminating tendonrotation while the retrieval device is attaching to the tendon end 772.

[0228] FIGS. 67-71 illustrate another alternative embodiment of thepresent invention employing analogous concepts to previous embodimentswherein at least one portion of an anchor structure moves with respectto another to a position at which tendon fibers are trapped between theportions and the anchor structure is affixed to an elongate tensilemember. In particular, an apparatus 800 is shown and comprises a pair ofanchor members 802, 804 which may be crimped together and simultaneouslycrimped within a tendon 806 and securely against an elongate tensilemember 808, such as a suture or other tensile member as described above.Each anchor member 802, 804 includes respective long legs 810 andrespective short legs 812 that register together in alternating fashionwhen in opposed relation as shown in FIG. 67 and as shown being appliedthrough opposite access incisions 814, 816 in FIG. 69.

[0229]FIGS. 68 and 69 illustrate a tool 820 having a pair of movablejaws 822, 824 used to apply anchor members 802, 804 to tendon 806. Jaws822, 824 include respective grippers 826, 828 for holding anchor members802, 804 in opposed relation as shown in FIG. 69. As further detailed inFIG. 68, each jaw 822, 824 includes pockets 830 that align with the endsof the legs 810, 812 of the opposed anchor member 802 or 804. A clip832, or other structure, may be provided to retain anchor member 802 and804 in place until the crimping operation is complete. As shown in FIGS.70 and 71, as jaws 822, 824 and grippers 826, 828 are brought togetherfrom the position shown in FIG. 69 to the position shown in FIGS. 70 and71, legs 810, 812 will be deformed or crimped permanently into theposition shown by respective pockets 830. At the locations proximatelonger legs 810, this will lock anchor members 802, 804 to the tendontissue 834 and, more specifically, to the tendon fibers comprisingtissue 834. At the area of proximate short legs 812, anchor members 802,804 will be crimped more directly onto elongate tensile member 808. Thisaction is brought about by the tapered angle of grippers 826, 828 asillustrated in FIG. 68 and by comparing FIGS. 70 and 71 which show thegrippers in the same actuated position.

[0230] In this embodiment, tool 820 may be actuated to a first positionsufficient to grip tendon fibers 834, but still allow sliding motionalong elongate tensile member 808. Using tool 820, or another method,tendon 806 may then be pulled to a repair position by sliding anchormembers 802, 804 along elongate tensile member 808. At the appropriaterepair position, the crimp may be finished by further actuating tool 820to the position shown in FIGS. 70 and 71. In a tendon-to-tendon repair,as with the previous embodiments, one pair of anchor members 802, 804may be rigidly affixed to tendon 806 in the manner illustrated in FIGS.70 and 71, on one side of a tear, and the sliding adjustment may beaccomplished in the opposite side of the tear followed by a finalcrimping action on a second set of anchor members 802, 804 as describedabove.

[0231] FIGS. 72-74 illustrate another apparatus similar to FIGS. 67-71,but employing a single anchor member 840 having respective long andshort legs 842, 844. The operation of this embodiment is similar to theprevious embodiment, except that only one of the opposed jaws wouldrequire an anvil surface, such as one comprised of recesses or pockets,in order to bend legs 842 into a position suitable for tightly grippingtendon tissue 834 against elongate tensile member 808 and also tightlydeforming legs 844 substantially directly against elongate tensilemember 808 as shown in FIG. 74. Again, this embodiment comprises ananchor structure having an anchor member 844 with at least one portionmovable with respect to another for gripping and compressing tendontissue therebetween. Furthermore, before the final crimping action takesplace, anchor member 840 can initially grip tissue 834 and move alongelongate tensile member 808 to a suitable repair position where upon thesurgeon may finally crimp anchor member 840 securely against elongatetensile member 808 as shown in FIG. 74. As further shown in FIG. 74,each access incision 814, 816 is then closed using stitches 846, 848 oranother suitable method.

[0232] Referring now to FIGS. 75 and 76, another embodiment of theinvention is described in connection with tendon-to-tendon orligament-to-ligament repair, however, it will be appreciated that thisembodiment will also be useful for other procedures. In this embodiment,an anchor assembly 850 is comprised of a helical anchor 852 and a coreportion or tendon fiber retaining member 854. Helical anchor 852 hasproximal and distal ends 856, 858 and retaining member likewise hasproximal and distal ends 860, 862. The distal end 858 of helical anchor852 extends distally beyond the distal end 862 of retaining member 854and is sharpened to a point 864 to aid in insertion. In addition,retaining member 854 is tapered at its distal end 862 creating a space866 between coils 852 a of the helical anchor 852 and the outsidesurface 868 of the retaining member 854 for receiving and retainingtendon or ligament fibers 870 therein at least at a location near distalends 858, 862. The proximal end 856 of helical anchor 852 is fixed to aproximal end portion 872 of retaining member 854. This may beaccomplished in various ways, however, in the preferred embodiment, theproximal end 856 is retained in a slot 874 and is welded such as througha laser or resistence welding operation. The proximal end 860 ofretaining member 854 includes a slot 876 for receiving an insertion tooland, if necessary, a removal tool to be described below. Slots 874, 876may communicate with each other as shown. Retaining member 854 includesa central longitudinal bore 878 for receiving an elongate, preferablyflexible, tensile member 880. Finally, a crimp member 882 is providedand may be a separate member with a central bore 884 for receipt onelongate flexible tensile member 880 or, as previously described, it maybe integral with retaining member 854 or a different type of lockingmember may be used instead.

[0233]FIGS. 77, 78 and 78A illustrate an anchor assembly insertion tool890 for inserting the anchor assembly 850 of FIG. 75 within a tendon orligament 892. Insertion tool 890 comprises an elongate body portion 894having a rotatable knob 896 at a proximal end 898 and having aneedle-shaped drive portion 900 at a distal end 902. A flexible cable orshaft 904 is coupled between knob 896 and needle-shaped drive portion900 and, in the preferred embodiment, this cable 904 is both rotated andtranslated as knob 896 is rotated in the direction of arrows 906. Athreaded coupling 908 within the elongate body portion 894 allows thesimultaneous rotation and translation around and along axis 912 as knob896 is rotated. Needle-shaped drive portion 900 is rigidly affixed toflexible cable 904 as shown in FIG. 78A through the use of a couplingmember 914 and, preferably, an anchor assembly 850 as shown in FIG. 75is retained within a curved, tubular housing 916 which does not rotatebut retains rotatable cable 904 therein. Needle-shaped drive portion 900includes a needle 918 which extends through anchor assembly 850 andfurther includes a projecting portion 920 which is complimentary to thetool engaging slot portion 876 of anchor assembly 850 and fits thereinto allows rotation and translation of assembly 850 as the needle 918 isboth rotated and translated into the tendon or ligament in the directionof arrow shown in FIG. 78A. As more specifically shown in FIG. 79,anchor assembly 850 is rotated and translated, or moved axially, into atendon or ligament 892 and fibers 870 are captured during this insertionprocess between the coils 852 a of anchor 852 and the outside surface868 of retaining member 854. During the insertion process, the coils 852a expand slightly outward away from the outer surface 868 of retainingmember 854 due to their inherent spring action and, also due to theirspring action, spring back to apply a force against the tendon orligament fibers 870 and against the outer surface 868 of the retainingmember 854. This forcefully traps fibers 870 and strengthens theconnection between anchor assembly 850 and the tendon or ligament fibers870.

[0234]FIGS. 80 and 80A illustrate a pistol grip device 940 for drivingthe shaft 904 of the tool 890 as generally shown in FIGS. 77 and 78.Device 940 replaces knob 896 to allow one-handed operation by a surgeon.In this embodiment, a firing lever 942 may be actuated toward a handle944 with a single hand of the surgeon to rotate the firing lever 942about a pivot 946 and thereby drive a rack gear 948 upwardly, via aconnecting pin 948 a, to rotate a pinion gear 950 coupled for rotationwith flexible shaft 904. In this embodiment, shaft 904 includes anexternally threaded portion 904 a and an internally threaded nut 952 isrigidly affixed, so as not to rotate, within device 940. Threadedportion 904 a engages the internal threads of nut 952 and as shaft 904rotates through the interaction of rack and pinion 948, 950, shaft 904also translates to the left, as viewed in FIG. 80, to move drive portion900 and anchor assembly 850 (FIG. 78A) into tendon or ligament 892.Alternatively, if a translation mechanism were not provided, the surgeoncould translate the anchor assembly 850 manually into the tendon orligament 892 by simultaneously pushing the pistol grip handle assembly940 while actuating the firing lever 942. Other forms of pistol grip orother one-handed actuators may be used and configured in any number ofways by those of ordinary skill to simultaneously rotate and,optionally, translate shaft 904.

[0235] FIGS. 81-87 illustrate one preferred method out of many possiblemethods for utilizing anchor assembly 850 of FIG. 75. In this regard,two anchor assemblies 850 are respectively driven into tendon orligament segments 892 a, 892 b as shown in FIG. 81 and in a manner suchas described above. An assembly 960 comprised of a distal needle 962coupled with a flexible elongate tensile member 880, such as amulti-filament suture, and a preset crimp member 964 crimped onto aproximal end 966 of elongate tensile member 880 is threaded through afirst one of the anchor assemblies 850 using a tool 968 until needle 962is positioned between tendon or ligament segments 892 a, 892 b as shownin FIG. 81. From the opposite side, a second tool 970 is used to threada capturing member, which may be a conventional syringe or vena-punctureneedle 972, through the second anchor assembly 850 and into the space974 between tendon or ligament segments 892 a, 892 b. The first needle962 is then captured by inserting its end into the hollow interior ofthe syringe needle 972 and the connected assembly is then withdrawnthrough the second anchor assembly 850 as shown in FIGS. 82 and 83.Alternatively, elongate tensile member 880 may be pushed through thesecond anchor assembly 850 without first being captured in space 974.

[0236] Tendon or ligament segments 892 a, 892 b are then drawn togetherusing the well-secured anchor assemblies 850 as shown in FIGS. 84 and85. Anchor assembly 850 in ligament segment 892 a is pulled by presetcrimp member 964 as anchor assembly 850 in ligament segment 892 b ispushed using crimp member 882 and a crimp tool 980. Crimp tool 980 isused to collapse crimp member 882 onto the flexible elongate tensilemember 880 to retain the second anchor assembly 850 in position withinsegment 892 b. The first anchor assembly 850 is retained in position bythe preset crimp member 964 as previously described. Thus, the tendon orligament segments 892 a, 892 b are held at the desired positionsrelative to each other as determined by the surgeon. The excess lengthof the elongate tensile member 880 is then cut with a cutting tool 982at a location adjacent the proximal end of the crimp member 882 asgenerally shown in FIG. 86 and, as shown in FIG. 87, the accessincisions are closed, such as by suturing, and a running suture, orother means, may be used to secure the ends of the tendon or ligamentsegments 892 a, 892 b.

[0237]FIG. 88 shows the jaws 990, 992 of crimp tool 980 in more detail.One jaw 990 includes a projection 990 a for collapsing crimp member 882against a recess 992 a formed in the jaw 992. The recess 992 a in theopposite jaw includes a ridge 994 which helps retain crimp member 882 inplace within the jaws 990, 992, such as during shipping and during useby the surgeon. As also shown in FIGS. 84 and 85, one or more flexiblebars 996 a, 996 b are provided between opposing handles 998 a, 998 b ofcrimp tool 980. These bars 996 a, 996 b retain the jaws 990, 992 atpredetermined positions which hold the crimp member 882 in place duringpackaging, shipping and storage, but prevent jaws 990, 992 from comingtogether during application of relatively light loads to prematurelycollapse the crimp member 882. During use by the surgeon, however, theflexible bar or bars 996 a, 996 b do not prevent manual actuation of thehandles 998 a, 998 b to bring the jaws 990, 992 together and collapsethe crimp member 882 as shown in FIG. 85.

[0238]FIGS. 89 and 90 illustrate a removal tool 1000 which, in certaincases, may be necessary to remove an anchor assembly 850. Specifically,removal tool 1000 is in the general form of a rotatable hand toolgenerally similar to a screwdriver. However, as shown in FIG. 90, tool1000 includes a head portion 1002 having a needle 1004 extending from adrive portion 1006. Needle 1004 extends through the central bore 878 ofanchor assembly 850 and drive portion 1006 engages slot 876 of anchorassembly in a manner similar to a screwdriver to allow rotation ofanchor assembly 850. In the configuration shown, counterclockwiserotation of tool 1000 and anchor assembly 850 will back the anchorassembly 850 out of the tendon or ligament 892, for example, if theanchor assembly 850 is malpositioned.

[0239] While the present invention has been illustrated by a descriptionof the preferred embodiments and while these embodiments have beendescribed in some detail, it is not the intention of the Applicants torestrict or in any way limit the scope of the appended claims to suchdetail. The present disclosure has been illustrative of many featureswhich may be modified, and configured in many different sizes dependingon the intended use. The various embodiments and features of theinvention may be used singularly or in various combinations not to belimited by the detail provided herein. Additional advantages andmodifications will readily appear to those skilled in the art. This hasbeen a description of the present invention, along with the preferredmethods of practicing the present invention as currently known. Variousaspects of this invention may be used alone or in differentcombinations. The scope of the invention itself should only be definedby the appended claims, wherein we claim:

1. Apparatus for repairing a tendon or ligament comprised of fibersextending in a lengthwise direction thereof, the apparatus comprising:an elongate tensile member adapted to extend within the interior of saidtendon or ligament; a first helical anchor configured for insertionwithin the interior of said tendon or ligament; and at least oneretaining member coupled with said elongate tensile member and operableto hold said helical anchor to said fibers extending within the interiorof said tendon or ligament.
 2. The apparatus of claim 1 furthercomprising: a second helical anchor; and at least one second retainingmember coupled with said elongate tensile member and operable to holdsaid second helical anchor to said tendon or ligament fibers, whereinsaid first and second helical members are adapted to be inserted intosaid tendon or ligament on opposite sides of an injured portion thereofand, together with said elongate tensile member, further adapted to holdsaid injured portion in a desired repair position.
 3. The apparatus ofclaim 2, wherein at least one of said first and second helical anchorsis couplable for movement along said elongate tensile member.
 4. Theapparatus of claim 1, wherein said first helical anchor is couplable formovement along said elongate tensile member.
 5. The apparatus of claim1, wherein said first helical anchor and said retaining member areconnected for movement along said elongate tensile member and adapted tobe fixed at a desired position.
 6. The apparatus of claim 1, whereinsaid first helical anchor further comprises a helically wound wire. 7.The apparatus of claim 1 further comprising retaining structureassociated with said retaining member for gripping said fibers againstsaid first helical anchor.
 8. The apparatus of claim 1, wherein saidretaining member is configured to be received within said first helicalanchor for holding said fibers between said retaining member and saidfirst helical anchor.
 9. The apparatus of claim 8, wherein saidretaining member includes at least one deformable portion adapted to belocked onto said elongate tensile member.
 10. The apparatus of claim 8,wherein said retaining member includes a slot to allow coupling of saidretaining member onto said elongate tensile member.
 11. The apparatus ofclaim 8 further comprising a slidably adjustable locking member forholding said retaining member to said elongate tensile member.
 12. Theapparatus of claim 11, wherein said locking member is integral with saidretaining member.
 13. The apparatus of claim 11, wherein said lockingmember is separable from said retaining member.
 14. The apparatus ofclaim 11, wherein said locking member is a crimp member.
 15. Theapparatus of claim 11, wherein said locking member and said retainingmember are each configured to slide independently along said elongatetensile member.
 16. The apparatus of claim 8, wherein said exteriorsurface of said retaining member is a discontinuous surface adapted toaid in holding said fibers between said retaining member and said firsthelical anchor.
 17. The apparatus of claim 16, wherein saiddiscontinuous surface further comprises a serrated edge.
 18. Theapparatus of claim 16, wherein said discontinuous surface furthercomprises threads.
 19. The apparatus of claim 8, wherein said elongatetensile member and said retaining member include respective engageableportions for holding said retaining member at a desired position alongsaid elongate tensile member.
 20. The apparatus of claim 1, wherein saidelongate tensile member further comprises a flexible suture.
 21. Theapparatus of claim 1, wherein said elongate tensile member furthercomprises a rigid member.
 22. The apparatus of claim 1, wherein at leastone of said elongate tensile member, said first helical anchor and saidretaining member is comprised of an absorbable material.
 23. Theapparatus of claim 1, wherein said retaining member further comprises ahelical structure.
 24. The apparatus of claim 23, wherein one of saidfirst helical anchor and said retaining member is sized to be receivedby the other of said first helical anchor and said retaining member toform inner and outer helical members.
 25. The apparatus of claim 24,wherein at least one of said first helical anchor and said retainingmember is movable toward the other to retain said tendon or ligamentfibers therebetween.
 26. The apparatus of claim 24, wherein said outerhelical member is collapsible toward said inner helical member to retainsaid tendon or ligament fibers therebetween.
 27. The apparatus of claim1, wherein said retaining member is a solid member with an outer surfaceand said helical anchor is collapsible onto said outer surface.
 28. Theapparatus of claim 27, wherein said outer surface is a discontinuoussurface adapted to trap said fibers against said helical anchor.
 29. Theapparatus of claim 1, wherein said first helical anchor is formed from aflexible suture material and said retaining member is adapted to beinserted into said tendon or ligament with said flexible suture materialdisposed generally helically about said retaining member and said tendonor ligament fibers held therebetween.
 30. The apparatus of claim 29,wherein said elongate tensile member is formed from a flexible suturematerial.
 31. The apparatus of claim 30, wherein said flexible suturematerial forming said elongate tensile member is of greater tensilestrength than said flexible suture material forming said helical anchor.32. The apparatus of claim 1, wherein said helical anchor has adiameter, a leading end and a trailing end, and said diameter variesbetween said leading and trailing ends.
 33. The apparatus of claim 32,wherein said diameter reduces in size in a direction from said leadingend to said trailing end.
 34. The apparatus of claim 32, wherein saiddiameter increases in size in a direction from said leading end to saidtrailing end.
 35. An apparatus for repairing a tendon or ligamentcomprised of fibers extending in a lengthwise direction thereof, theapparatus comprising: first and second helical anchors integrally formeda wire with an elongate tensile member therebetween, said anchors beinghelically wound in opposite directions; and wherein said first andsecond helical members are adapted to be inserted into said tendon orligament on opposite sides of an injured portion thereof and, togetherwith said elongate tensile member, further adapted to hold said injuredportion in a desired repair position.
 36. Apparatus for repairing atendon or ligament comprised of fibers extending in a lengthwisedirection thereof, the apparatus comprising: an elongate tensile memberadapted to extend within the interior of said tendon or ligament; and afirst helically coiled, compressible anchor configured for insertionwithin the interior of said tendon or ligament, said anchor beingcouplable with said elongate tensile member and being compressibleduring use to trap the fibers of said tendon or ligament therein. 37.The apparatus of claim 36 further comprising: a second helically coiled,compressible anchor configured for insertion within the interior of saidtendon or ligament and couplable to said elongate tensile member;wherein said first and second helically coiled, compressible anchors areadapted to be inserted into said tendon or ligament on opposite sides ofan injured portion thereof and, together with at least said elongatetensile member, further adapted to hold said injured portion in adesired repair position.
 38. The apparatus of claim 37, wherein at leastone of said first and second helically coiled, compressible anchors iscoupled for movement along said elongate tensile member.
 39. Theapparatus of claim 36 further comprising a slidable locking membercoupled with said elongate tensile member and adapted to hold said firsthelically coiled, compressible anchor at a desired location on saidelongate tensile member.
 40. The apparatus of claim 39, wherein saidslidable locking member is integral with said helically coiled,compressible anchor.
 41. The apparatus of claim 39, wherein saidslidable locking member is separable from said first helically coiled,compressible anchor.
 42. The apparatus of claim 39, wherein saidslidable locking member is a crimp.
 43. The apparatus of claim 39,wherein said first helically coiled, compressible anchor includes alength and further includes a diameter that varies along said length.44. Apparatus for affixing a tendon or ligament to a bone, the apparatuscomprising: an elongate tensile member adapted to extend within theinterior of said tendon or ligament; a helical anchor receiving saidelongate tensile member and configured to be placed within the tendon orligament; and a bone anchor coupled with said elongate tensile memberfor allowing attachment of said tendon or ligament to said bone.
 45. Theapparatus of claim 44 further comprising: a retaining member adapted tobe retained at a selected position along said elongate tensile member tohold said bone anchor, said elongate tensile member and said helicalanchor together with said tendon or ligament against said bone.
 46. Theapparatus of claim 45, wherein said retaining member and said boneanchor include cooperating locking portions for connecting saidretaining member and said bone anchor together with said helical anchorheld generally there between.
 47. The apparatus of claim 45, whereinsaid retaining member is sized and configured to be received at leastpartially within said helical anchor.
 48. The apparatus of claim 47further comprising a slidable locking member coupled with said elongatetensile member and adapted to hold said retaining member at a desiredlocation along said elongate tensile member.
 49. The apparatus of claim48, wherein said slidable locking member is separable from saidretaining member.
 50. The apparatus of claim 48, wherein said slidablelocking member is formed integrally with said retaining member.
 51. Theapparatus of claim 48, wherein said slidable locking member is a crimpmember.
 52. The apparatus of claim 44, wherein said helical anchor iscompressible.
 53. Apparatus for repairing a tear in a tendon or ligamentcomprised of fibers extending in a lengthwise direction thereof, theapparatus comprising: an elongate tensile member adapted to extendwithin the interior of said tendon or ligament; a first helical anchorconfigured for insertion within the interior of said tendon or ligament;a first retaining member coupled with said elongate tensile member andconfigured to be at least partially received within said first helicalanchor to hold a portion of the fibers to said first helical anchor; asecond helical anchor configured for insertion within the interior ofsaid tendon or ligament; and a second retaining member coupled with saidelongate tensile member and configured to be at least partially receivedwithin said second helical anchor to hold a portion of the fibers tosaid second helical anchor.
 54. The apparatus of claim 53, wherein saidfirst and second retaining members each include at least one deformableportion adapted to be locked onto said elongate tensile member.
 55. Theapparatus of claim 54, wherein said first and second retaining memberseach include a slot to allow the respective deformable portions to belocked onto said elongate tensile member.
 56. The apparatus of claim 53further comprising first and second slidable locking members forrespectively holding said first and second retaining members to saidelongate tensile member.
 57. The apparatus of claim 56, wherein saidslidable locking members further comprise crimp members integrallyformed on said first and second retaining members.
 58. The apparatus ofclaim 56, wherein said slidable locking members are crimp members formedseparately from said retaining member, each being configured to slideindependently along said elongate tensile member.
 59. The apparatus ofclaim 53, wherein said first and second retaining members each havediscontinuous outer surfaces for holding said fibers respectivelybetween said first and second retaining members and said first andsecond helical anchors.
 60. The apparatus of claim 59, wherein saiddiscontinuous surfaces further comprise serrated edges.
 61. Theapparatus of claim 59, wherein said discontinuous surfaces furthercomprise threads.
 62. The apparatus of claim 53, wherein said elongatetensile member and said first and second retaining members includerespective engageable portions for holding said retaining members atdesired positions along said elongate tensile member.
 63. The apparatusof claim 53, wherein said elongate tensile member further comprises aflexible suture.
 64. The apparatus of claim 53, wherein at least one ofsaid elongate tensile member, said first helical anchor, said secondhelical anchor, said first retaining member, and said second retainingmember further comprise an absorbable material.
 65. The apparatus ofclaim 53, wherein said first and second helical anchors have respectivediameters and include respective leading and trailing ends, and saiddiameters each vary between said leading and trailing ends.
 66. Theapparatus of claim 65, wherein s aid diameters each reduce in size in adirection from said t railing ends toward said leading ends.
 67. Theapparatus of claim 53, wherein each of said first and second helicalanchors is formed from wire.
 68. The apparatus of claim 67, furthercomprising a drive portion at a trailing end of each helical anchor forengaging a tool used to rotate the respective helical anchor into thetendon or ligament.
 69. The apparatus of claim 53 further comprising atool engageable with at least one of said first and second helicalanchors for rotating said at least one helical anchor into the tendon orligament.
 70. The apparatus of claim 53, wherein said first helicalanchor is connected for movement along said elongate tensile member andfurther comprising locking structure operable to lock said first helicalanchor at a desired position along said elongate tensile member. 71.Apparatus for repairing a tendon or ligament comprised of fibersextending in a lengthwise direction thereof, the apparatus comprising:an elongate tensile member having a length adapted to extend within theinterior of said tendon or ligament; and a first anchor structurecoupled for movement along the length of said elongate tensile memberand lockable at a desired location along said length, said first anchorstructure having first and second fiber gripping portions configured forinsertion within the interior of said tendon or ligament, at least oneof said fiber gripping portions being movable relative to the other togrip said fibers therebetween.
 72. The apparatus of claim 71, whereinsaid first fiber gripping portion is a helical anchor and said secondfiber gripping portion is a retaining member coupled for movement alongsaid elongate tensile member and configured to be at least partiallyreceived within said helical anchor.
 73. The apparatus of claim 72,wherein said retaining member includes structure configured to engagesaid helical anchor to prevent said retaining member from backing out ofsaid helical anchor after implantation.
 74. The apparatus of claim 72,wherein said retaining member is a one-piece slotted collet memberconfigured to clamp onto said elongate tensile member upon insertioninto said helical anchor.
 75. The apparatus of claim 72, wherein saidretaining member is a two-piece slotted collet structure with aninterior piece and an exterior piece, whereby upon insertion of saidexterior piece into said helical anchor and said interior piece intosaid exterior piece, said interior piece is configured to clamp ontosaid elongate tensile member and said exterior piece is configured toexpand within said helical anchor to trap said fibers against saidhelical anchor.
 76. The apparatus of claim 71, wherein said anchorstructure further comprises at least one crimp member and said one ofsaid fiber gripping portions further comprises a first deformableportion adapted to be crimped within said tendon or ligament to gripsaid fibers.
 77. The apparatus of claim 76, wherein said crimp memberfurther comprises a second deformable portion configured to be crimpedonto said elongate tensile member to retain said crimp member at adesired location thereon.
 78. The apparatus of claim 71, wherein saidanchor structure further comprises first and second crimp membersadapted to be crimped onto said fibers on opposite sides of saidelongate tensile member.
 79. The apparatus of claim 78, wherein saidfirst and second crimp members each include a respective plurality ofdeformable legs configured to interlock after crimping and thereby holdsaid first and second crimp members to said fibers.
 80. The apparatus ofclaim 78, wherein said first and second crimp members further includerespective crimp portions configured to be crimped onto said elongatetensile member to retain said first and second crimp members at adesired location thereon.
 81. The apparatus of claim 71, wherein saidanchor structure comprises a compressible helical anchor having coilsdefining said first and second fiber gripping portions.
 82. Theapparatus of claim 71, wherein said first anchor structure furthercomprises inner and outer helical member s wi th said inner helicalmember sized and configured to be positioned within said outer helicalmember.
 83. The apparatus of claim 82, wherein said inner helical memberis expandable within said outer helical member to retain said tendon orligament fibers therebetween.
 84. The apparatus of claim 72, whereinsaid outer helical member is collapsible toward said inner helicalmember to retain said tendon or ligament fibers therebetween.
 85. Theapparatus of claim 71 further comprising: a second anchor structurecoupled for movement along the length of said elongate tensile andadapted to be located on an opposite side of a repair site from saidfirst anchor structure, said second anchor structure being lockable onsaid elongate tensile member.
 86. The apparatus of claim 85, whereinsaid second anchor structure further comprises first and second fibergripping portions configured for insertion with said tendon or ligamentwith at least one of said fiber gripping portions being movable relativeto the other to grip said fibers therebetween.
 87. The apparatus ofclaim 71, wherein said first anchor structure further comprises an innerretaining member and an outer helical member with said inner retainingmember sized and configured to be positioned within said outer helicalmember and said outer helical member is collapsible toward said innerretaining member to retain said tendon or ligament fibers therebetween.88. A tendon or ligament retrieval device operative to move a tendon orligament end to a desired operating position, the device comprising: anelongate body; a helical member coupled with said elongate body andmounted for rotational and translational movement relative to saidelongate body; at least one drive mechanism coupled with said helicalmember for effecting rotational movement of said helical member intosaid tendon or ligament and subsequent translational movement of saidhelical member to move said tendon or ligament end to the desiredoperating position.
 89. The device of claim 88, wherein said elongatebody includes a distal tip and further comprising: anti-rotationstructure on said distal tip for engaging said tendon or ligament endand preventing rotation thereof as said helical member rotates into saidtendon or ligament end.
 90. The device of claim 88, wherein saidelongate body is a hollow, flexible body.
 91. The device of claim 88,wherein said helical member further includes first and second,counter-rotating helical grasping bodies each being connected forrotation and translation by said drive mechanism.
 92. A method ofrepairing a tendon or ligament comprised of fibers extending in alengthwise direction thereof and having a tear, the method comprising:installing an elongate tensile member within said tendon or ligament;driving a first helical anchor into said tendon or ligament; securingsaid first helical anchor to said elongate tensile member; driving asecond helical anchor into said tendon or ligament; moving the tendon orligament to a repair position at said tear; and securing the secondhelical anchor to said elongate tensile member.
 93. The method of claim92, wherein the steps of securing said first and second helical anchorsfurther comprise gripping the fibers between said first and secondhelical anchors and a pair of respective first and second retainingmembers.
 94. The method of claim 92, wherein adjusting the tendon orligament further comprises: moving said elongate tensile member withrespect to at least one of said first and second helical anchors andthereby approximating the tendon or ligament to said repair position.95. The method of claim 92, wherein said tendon includes a sheath andthe method further comprises forming at least two spaced apart incisionsin said sheath to access said tendon during said securing and adjustingsteps.
 96. A method of repairing a tendon or ligament comprised offibers extending in a lengthwise direction thereof and having a tear,the method comprising: inserting an elongate tensile member into saidtendon or ligament and extending across said tear; rotating a firsthelical anchor around said elongate tensile member and into the interiorof said tendon or ligament on a first side of said tear; locking saidfirst helical anchor to said elongate tensile member and said fibers;rotating a second helical anchor around said elongate tensile member andinto the interior of said tendon or ligament on a second side of saidtear; adjusting the distance between the first and second helicalanchors along said elongate tensile member to bring the first and secondsides together to a repair position generally at said tear; and lockingsaid second helical anchor to said elongate tensile member and saidfibers after reaching said repair position.
 97. The method of claim 96,wherein locking the first and second helical anchors to the fibersfurther comprises collapsing the first and second helical anchors towardrespective first and second retaining members using magnetic force. 98.Apparatus for repairing a tear in a tendon or ligament, the apparatuscomprising: an elongate tensile member adapted to extend within theinterior of said tendon or ligament from a first side of said tear to asecond side of said tear; a first anchor body connected with saidelongate tensile member, said first anchor body configured for insertionwithin the interior of said tendon or ligament; first securing structureoperable to at least assist in holding said first anchor body within theinterior of said tendon or ligament on the first side of said tear; asecond anchor body connected for movement along said elongate tensilemember, said second anchor body configured for insertion and retentionwithin the interior of said tendon or ligament; second securingstructure operable to at least assist in holding said second anchor bodywithin the interior of said tendon or ligament on the second side ofsaid tear; and locking structure operable to hold said second anchorbody at a desired distance from said first anchor body along saidelongate tensile member.
 99. The apparatus of claim 98, wherein saidfirst and second securing structure comprises projections extendingrespectively from said first and second anchor bodies generally in aradially outward direction with respect to said elongate tensile member.100. The apparatus of claim 99, wherein said first and second anchorbodies are tubular-shaped members.
 101. The apparatus of claim 98,wherein said first and second anchor bodies are tubular-shaped members.102. The apparatus of claim 98, wherein said first and second securingstructures further comprise portions connected with said first andsecond anchor bodies, said portions receiving sutures used to securesaid first and second anchor bodies within the interior of said tendonor ligament.
 103. The apparatus of claim 98 further comprising a toolselectively engageable with at least one of said first and second anchorbodies for inserting said at least one anchor body within the tendon orligament.
 104. The apparatus of claim 98, wherein at least one of saidfirst and second anchor bodies is swageable to said elongate tensilemember.
 105. The apparatus of claim 98, wherein said first anchor bodyis connected for movement along said elongate tensile member and furthercomprising locking structure operable to lock said first anchor body ata desired position along said elongate tensile member.
 106. Theapparatus of claim 98, wherein said first and second securing structuresare integral parts of the respective first and second anchor bodies.107. A method of repairing a tendon or ligament having a tear, themethod comprising: connecting a first anchor body to an elongate tensilemember; securing said first anchor body within the interior of saidtendon or ligament on a first side of said tear; connecting a secondanchor body to said elongate tensile member; securing said second anchorbody within the interior of said tendon or ligament on a second side ofsaid tear; adjusting the distance between the first and second anchorbodies along said elongate tensile member to bring the first and secondsides together at said tear; and holding the first and second sidestogether at said tear with at least said anchor bodies and said elongatetensile member.
 108. The method of claim 107, wherein the steps ofsecuring said first and second anchor bodies further comprise engagingsaid tendon or ligament with projections on said first and second anchorbodies.
 109. The method of claim 108, wherein the steps of securing saidfirst and second anchor bodies further comprise separately suturing saidfirst and second anchor bodies within said tendon or ligament.
 110. Themethod of claim 107, wherein the steps of securing said first and secondanchor bodies further comprise separately suturing said first and secondanchor bodies within said tendon or ligament.
 111. The method of claim107, wherein adjusting the distance between the first and second anchorbodies further comprises sliding one of said first and second anchorbodies along said elongate tensile member while pulling the first andsecond sides together with said elongate tensile member under tension.112. The method of claim 107, wherein at least two spaced apartincisions are made to access said tendon or ligament during saidsecuring and adjusting steps.
 113. The method of claim 107 furthercomprising: swaging said first and second anchor bodies to said elongatetensile member at the adjusted distance.
 114. A method of repairing atendon or ligament having a tear, the method comprising: inserting afirst anchor body and an elongate tensile member connected therewiththrough the interior of said tendon or ligament and across said tear;securing said first anchor body within said tendon or ligament;connecting a second anchor body to said elongate tensile member;inserting said second anchor body within said tendon or ligament on anopposite side of said tear from said first anchor body while allowingmovement of said second anchor body along said elongate tensile member;pulling the tendon or ligament together by tensioning the elongatetensile member between said first and second anchor bodies; and fixingsaid second anchor body on said elongate tensile member at a locationwhich holds the elongate tensile member in tension and holds the tendonor ligament together at said tear.
 115. A method of repairing a tendonor ligament having a tear, the method comprising: connecting a firstanchor body to an elongate tensile member; securing said first anchorbody within the interior of said tendon or ligament on a first side ofsaid tear; securing a second anchor body within the interior of saidtendon or ligament on a second side of said tear; tensioning theelongate tensile member to adjust the distance between the first andsecond anchor bodies and bring the first and second sides together atsaid tear; and holding the first and second sides together at said tearwith at least said anchor bodies and said elongate tensile member. 116.Apparatus for repairing a tendon or ligament comprised of fibersextending in a lengthwise direction thereof, the apparatus comprising:an elongate tensile member adapted to extend within the interior of saidtendon or ligament; a first anchor configured for insertion within theinterior of said tendon or ligament; and a first retaining membercoupled with said first anchor and configured therewith to allowsimultaneous driving of said first anchor and said first retainingmember into the interior of said tendon or ligament with the fibers ofthe tendon or ligament held generally between said first anchor and saidfirst retaining member.
 117. The apparatus of claim 116, wherein saidfirst anchor further comprises a helical coil.
 118. The apparatus ofclaim 117, wherein said helical coil includes a distal end and saidfirst retaining member includes a distal end, and said distal end ofsaid helical coil extends distally beyond said distal end of said firstretaining member.
 119. The apparatus of claim 117, wherein said firstretaining member includes a distal end portion and an outer surface, anda space is formed between said helical coil and said outer surface atleast at said distal end portion, said space receiving and retaining thefibers between said helical coil and said first retaining member. 120.The apparatus of claim 119, wherein said helical coil is radiallyexpandable and compressible such that as the fibers are directed intosaid space during insertion said coil expands to receive the fibers andcompresses to hold the fibers against said first retaining member. 121.The apparatus of claim 117, wherein said helical coil includes a pointeddistal end to aid in insertion thereof in said tendon or ligament. 122.The apparatus of claim 117, wherein said helical coil includes aproximal end secured to a proximal end portion of said first retainingmember.
 123. The apparatus of claim 122, wherein said proximal endportion of said first retaining member includes a slot, and saidproximal end of said helical coil is secured in said slot.
 124. Theapparatus of claim 117, wherein said helical coil and said firstretaining member include low friction, polished outer surfaces.
 125. Theapparatus of claim 116, wherein said first retaining member furtherincludes a proximal end portion with tool engagement structure operativeto engage a tool configured to simultaneously insert said first anchorand said first retaining member in said tendon or ligament.
 126. Theapparatus of claim 116 further comprising: a second anchor; and a secondretaining member coupled with said second anchor and configuredtherewith to allow simultaneous driving of said second anchor and saidsecond retaining member into the interior of said tendon or ligamentwith the fibers of the tendon or ligament held generally between saidsecond anchor and said second retaining member. wherein said firstanchor and first retaining member and said second anchor and secondretaining member are respectively adapted to be inserted into saidtendon or ligament on opposite sides of an injured portion thereof and,together with said elongate tensile member, further adapted to hold saidinjured portion in a desired repair position.
 127. The apparatus ofclaim 116, wherein said first anchor and said first retaining member arecouplable for movement along said elongate tensile member.
 128. Theapparatus of claim 116, wherein said first retaining member includes aproximal end portion and a bore for receiving said elongate tensilemember further includes a needle secured at one end thereof and a stopmember secured at an opposite end thereof, said needle being configuredto extend through said bore and said stop member being configured tostop against said proximal portion of said first retaining member. 129.The apparatus of claim 116 further comprising a tool configured to holdsaid first anchor and said first retaining member and further configuredto allow simultaneous rotation and translation of said first anchor andsaid first retaining member into said tendon or ligament by a user. 130.A fixation device for repairing a tendon or ligament, comprising: aflexible, elongate tensile member having a first end and a second end; aneedle affixed at said first end; a first stop member fixed at saidsecond end; and first and second anchor members configured to beinserted and retained in the tendon or ligament and having respectivebores for receiving said elongate tensile member.
 131. The apparatus ofclaim 130 further comprising: a second stop member capable of beinglocked onto said elongate tensile member.
 132. The apparatus of claim131, wherein said second stop member further comprises a crimp member.133. An apparatus for repairing a tendon or ligament, comprising: atubular housing having an open distal end; a rotatable shaft carriedwithin said tubular housing and having proximal and distal portions, atendon or ligament anchor assembly having a central bore and a proximalend, said anchor assembly carried within said tubular housing, aneedle-shaped member affixed at said distal end of said shaft andextending through said central bore of said anchor assembly; a drivemember at said distal end of said shaft engaging said proximal end ofsaid anchor assembly; a drive coupled to said second end and operativeto rotate said shaft within said housing and thereby rotate said anchorassembly.
 134. The apparatus of claim 133, wherein said shaft isflexible and said distal end of said tubular housing is curved to allowentry into said tendon or ligament.
 135. The apparatus of claim 133,wherein said drive comprises a rotatable knob.
 136. The apparatus ofclaim 133, wherein said drive comprises an actuator configured forone-handed operation by a surgeon.
 137. A crimping tool comprising:first and second jaws movable toward each other, said first jawincluding a recess with a ridge in said recess for holding a crimpmember having a complementary groove for receiving said projection, saidsecond jaw having a projection for bearing against and collapsing thecrimp member; and first and second handles respectively connected tosaid first and second jaws for moving said jaws together against thecrimp member to collapse the crimp member.
 138. The crimping tool ofclaim 137, further comprising: at least one bar extending between saidhandles and configured to allow movement of said handles together uponapplication of a predetermined force.
 139. A method of repairing atendon or ligament comprised of fibers extending in a lengthwisedirection thereof and having first and second segments, the methodcomprising: driving a first anchor into the first segment of the tendonor ligament; driving a second anchor into the second segment of thetendon or ligament; threading an elongate tensile member through thefirst and second anchors; moving the first and second segments to arepair position; and securing the first and second anchors at a desireddistance relative to each other along said elongate tensile member. 140.The method of claim 139, wherein the steps of driving said first andsecond anchors further comprise gripping the fibers between said firstand second anchors and a pair of respective first and second retainingmembers.
 141. The method of claim 139, wherein adjusting the tendon orligament further comprises: moving said elongate tensile member withrespect to at least one of said first and second anchors and therebyapproximating the tendon or ligament to said repair position.
 142. Themethod of claim 139, wherein the step of threading the elongate tensilemember further comprises: capturing the elongate tensile member in aspace between the first and second segments, and pulling the capturedelongate tensile member through the second anchor.
 143. The method ofclaim 139, wherein the elongate tensile member further includes a needleat one end and a stop member at an opposite end and the step ofthreading the elongate tensile member further comprises: inserting theneedle through the first anchor and the second anchor until the stopmember engages and stops against the first anchor.
 144. The method ofclaim 143, wherein the step of securing the first and second anchors ata fixed distance further comprises: applying a crimp member to theelongate tensile member at the proximal end of the second anchor.
 145. Aretrieval tool for removing an anchor having a central bore, a proximalend with tool engagement structure and a distal end for insertion into atendon or ligament, the retrieval tool comprising: a handle portion; ashaft coupled to said handle portion; a tool driver portion coupled tosaid shaft and configured to engage said tool engagement structure onthe anchor to enable rotation of the anchor by rotation of said shaft;and a needle-shaped member extending from said tool driver portion andconfigured to be received in the bore of the anchor.